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DATOSPIR-110/120 SPIROMETER 511-800-MU2 Rev

1. 0 0 0 0 Z N N N N N N ff O O O O 9 S dae s 511 800 MU2 Rev 2 02 2013 10 9 PROCEDURE FOR SLOW VITAL CAPACITY TEST VC 10 PROCEDURE FOR THE MAXIMAL VOLUNTARY VENTILATION TEST MVV 1 11 PROCEDURE FOR THE POSTBRONCHODILATION TEST 1 12 PROCEDURE FOR THE BRONCHOCONSTRICTION OR BRONCHIAL PROVOCATION TEST 1 12 1 DESCRIPTION OF THE TEST 1 12 2 INPUT OF TEST DATA 1 12 3 PROCESS OF THE TEST 1 12 4 TEST SUMMARY 1 13 PROCEDURE TO PERFORM THE CALIBRATION CAL J 13 1 GENERAL OBSERVATIONS 1 13 2 TYPES OF TRANSDUCERS 1 13 3 PROCESS FOR CALIBRATION 1 13 4 CALIBRATIONS RECORD 1 14 INTERNAL DATABASE 1 15 MAINTENANCE PROGRAM 1 TRANSFER OF DEVICE CHECK DATA AND OF THE DATABASE 3 PATIENT TESTS MANAGEMENT IN THE PC 4 EXPORT OF TESTS TO OTHER SYSTEMS MUNICATIONS SYSTEM 1 IRANSFER OF DEVICE CHECK DATA AND OF THE DATABASE 2 SOFTWARE UPDATING 6 3 PATIENT TESTS MANAGEMENT IN THE PC 16 4 EXPORT OF TESTS TO OTHER SYSTEMS 1 17 SPIROMETRY SOFTWARE W 20 FOR PC 2 2 di 1 16 M 6 6 2 TECHNICAL SPECIFICATIONS 2 1 TYPES OF TESTS FUNCTIONS AND SPIROMETRIC PARAMETERS 2 1 1 FVC FORCED VITAL CAPACITY SLOW VITAL CAPACITY MAXIMAL VOLUNTARY VENTILATION BRONCHODILATATION TEST BRONCHOCONSTRICTION TEST PULSE OXIMETRY SpO2 MAXIMAL RESPIRATORY PRESSURES CALIBRATION
2. I 8 To fe marj uwa J ibas The disposable transducer incorporates a calibration factor which permits the exchange ofthe transducer without having to perform any calibration Each transducer will have associated a correction factor When executing each one of the tests verification that the transducer factor is the same than the one appearing in the unit s display must be done All the functions are accessible from the eight keys F1 to F8 located in the left side F1 to F4 and right F5 to F8 of the display On the bottom of the screen some icons can appear which are associated to nu meric keys 1 to 5 Furthermore the device has a help system on screen which describes the meaning of each icon briefly as well as other information that eases the use of the device This help is shown by pressing the key at any moment 511 800 MU2 Rev 2 02 2013 10 The DATOSPIR 120 spirometer has a help system on screen which sim Plifies the use and explains the maning of the different icons DATA BASE Program COHFIGIRATIOH Program CALIBRATION Program PULSE OXIMETRY Program MAXIMAL PRESSURES Program Consult the User s Manual for fur ther information 16 25 1999 11 57 1 5 4 LOADING THE PAPER IN THE PRINTER The B C and D models work with thermosensitive paper of 111 mm wide and model Awith thermosensitive paper of 58 mm wide In
3. DOS EZ RESPOPESE GRAPHICS PREG mg ml 15 50 Inhalations The graphic dose response is shown mathematically adjusted through a process of logarithmic adjustment y C1 C2 log x if the coefficient of determination is better of 80 In this case the calculation of PD20 is made solving it in the adjust ment equation If the coefficient of determination is lower than 80 the graphic is presented linearly and the calculation of PD20 is made by linear interpolation 5th Step CONSTRICTION DILATATION DIL When finishing this test if you need to give the patient a bronchodilator drug to revert the resultant bronchoconstriction press key F4 in the data screen of the previous display COMSTRICTIOM TEST 3 89 4 22 2 94 3 50 65 26 82 91 Dose tmog ml BD drug SALBUTAMOL Best FEU1 2 5 5 Harnin References Enter the data for the bronchodilator drug and press F7 Apply the bronchodilator to the patient After the normalised time perform a series of manoeuvres Store the best manoeuvre and repeat the previous process if necessary 511 800 MU2 Rev 2 02 2013 10 1 12 4 TEST SUMMARY The summary of the bronchoconstriction test is presented in a graphic way graphic dose response shown before or numerically summary of the data shown next Go to the summary pressing key F4 on the screen of graphics COMETRICTION SUMMARY ama na cofi Bo g t tapa
4. 511 800 MU2 Rev 2 02 2013 10 1 8 2 INPUT OF FORCED VITAL CAPACITY TESTS FVC F2 Activates the incentive mode F4 Enables to modify the Patient and environmental data F5 Starts the manoeuvre F6 Changes the type of graphic Flow Volume or Volume Time F8 Keyto introduce the Disposable Factor only if the disposable transducer is connected Itis convenient that the user who performs the forced spirometry tests knows the usual procedure required so that the patient does the test correctly Oth erwise it is advisable to check some information regarding this matter In the performance of this spirometry take into account the following steps 1 Connect the transducer in the connector no 7 The device detects automati cally the type of transducer to which it is connected Neumotachometer type Fleisch Transducer type turbine Transducer type disposable When the transducer is a disposable the calibration factor introduced in the unit will appear above the curve s zone Moreover the first time getting in the testing screen F8 key will be activated to be able to change the factor For all the tests performed in the DATOSPIR 110 120 the neumotachometer type Fleisch must by at 37 C except during the device calibration which must be at room temperature If the neumotachometer is not working at temperature 37 C a label appears 511 800 MU2 Rev 2 02 2013 10 warning about this circumstance The
5. Test of POSTbronchodilatation FA Test of Bronchoconstriction or Bronchial Provocation F5 Forced Vital Capacity Test F6 Slow Vital Capacity Test F7 Maximal Voluntary Ventilation test F8 General report if it appears The general report displays the FVC VC MVV tests altogether performed to the same patient Press F5 511 800 MU2 Rev 2 02 2013 10 1 8 1 INPUT OF PATIENT AND ENVIRONMENTAL PARAMETERS SPLRCMET iy Code 122456570584 43 Hiem 52 1 amp wkm r ae Etr rav MANUEL PEREZ GUTIERREZ TECH 5 HC Fill in the parameters in according to F2 F3 F4 and F8 F8 F5 and F6 F7 Enables to insert a character if it appears Deletes a character Moves the cursor to the left or right inside the same field for text fields like Name and Surn Shows the screen where to introduce the factor when itis a disposable Returns the cursor to the previous field or advances it to the next one Validates the entered data and goes to the next screen The alphanumeric characters are entered through the keyboard of the device Each key has different alphanumeric characters associated for example key 3 has also D E and F With the first hit in an alphanumeric field the 3 is presented with the second one the D with the third one the E and with the fourth one the F provided that the time between hit
6. The converter used at DATOSPIR 110 120 has 12 bits so it has 4096 levels for the pressure signal The 2048 upper levels are used for the expiratory flows and the 2048 bottom levels are used for inspiratory flows The resolution and range of the converter meet or exceed the international organ isms requirements 3 8 MICROPROCESSOR 3 8 1 PHYSICAL DESCRIPTION Some electronic devices that store manage receive and transmit information com pose the microprocessor system It can be divided in some parts Program of basic hardware control BIOS that is located in 32 Kbytes EPROM Spirometry Management Program and Test Database that are located in 1Mbyte FLASH memory No volatile 128 Kbytes RAM memory that storesthe device configuration status variables and calibration database Central Processing Unit CPU External Communication Controller Clock Calendar 511 800 MU2 Rev 2 02 2013 10 3 8 2 PROGRAM The control program is developed in assembler language and C high level language This characteristic assures a fast time control and structured programming It is divided in two parts the bios in EPROM and the application in FLASH memory 3 8 3 MEMORY The temporal data storing device configuration and calibration database capacity is 128 Kbytes in non volatile RAM The Test Database has a maximum capacity of 320KB and it is located in FLASH memory 3 8 4 CPU This device manages and executes the process that
7. The device is used by qualified personnel and according to the recom mendations of this Use Manual 511 800 MU2 Rev 2 02 2013 10 1 4 DISTRIBUTION OF CONTROLS INDICATORS AND CONNECTORS 1 4 1 GENERAL PANNEL No 1 Housing of paper and internal printer of 112 or 58 mm No 2 Lever to lock or unlock the pull paper roll No 3 Backlighted liquid crystal display of 320 x 240 pixels 511 800 MU2 D ev 2 02 2013 10 espir m tro DATOSPIR 1200 PEFRSOMALIZACION DE ESPIROMETRIA 8 m a Jibola No 4 Function keys F1 to F8 for handling the device No 5 Graphic icons indicating the functions No 6 Keyboard of tactile membrane with Stop Start Key Light indicator type LED to start and other functions Alphanumeric keyboard Key to display help on the screen 511 800 MU2 Rev 2 02 2013 10 1 4 2 RIGHT AND LEFT SIDE No 7 Connection of the spirometric transducer No 8 Connection of the pulse oximetry sensor SpO2 No 9 Connection of the Maximal Respiratory Pressures MIP MEP No 10 Characteristics board 511 800 MU2 Rev 2 02 0 1 4 3 BACK PANNEL No 11 Serial communications channel RS 232C No 12 Connection to the mains power supply No 13 Connection for external parallel printer No 14 Base for the connection of additional prot
8. 1 mI z 6 pem 47 3 gz sa ud 65 34 PEF FEF 23 73 F2 Presents the graphic dose response F5 y FG Show the following values F7 Prints the summary of the test F8 Stores the test summary in the internal database Take into account that the observed values are compared according to Basal with the selected Reference of the patient Diluent if made with the Basal Constriction with the Diluent if made Otherwise with the Basal Dilatation with the Basal 511 800 MU2 e Rev 2 02 2013 10 1 13 PROCEDURE TO PERFORM THE CALIBRATION CAL 1 13 1 GENERAL OBSERVATIONS As indicated above the existent standards for spirometry recommend that all the spirometers have to be calibrated periodically This is due to the alterations that can modify the characteristics of the electronic circuits and mechanical elements causing a change in the calibration factors of spirometers For this reason we have included a calibration system from a signal of reference volume for example a syringe This calibration factor must take into consideration the changes in volume associ ated to the environmental conditions temperature relative humidity and barometric pressure The most influent factor is the temperature and the humidity degree The DATOSPIR 110 120 has incorporated a Calibration Program which enables easy and quickly less than two minutes to verify and self correct the measure me
9. POLGAR WENG 4 to 100 years HANKINSON 4 to 100 years PEREZ PADILLA MEXICO 7 to 100 For ages lt 7 years reference values are extrapolated A J CRUZ MEXICO 17 to 64 For ages 17 years reference values are extrapolated 511 800 MU2 Rev 2 02 0 5 PRESERVATION PREVENTIVE AND CORRECTIVE MAINTENANCE The DATOSPIR 110 120 spirometer requires as every equipment and especially if it is for medical applications even more a preservation or maintenance directed in the first place to the safety of the patient operator and the environment and secondly to insure the reliability and accuracy of the functions for which it has been developed All this comports a series of routines which must be executed 5 1 PRESERVATION Preservation is the action directed to maintain the equipment in a correct opera ting condition and the person performing this does not need any special technical quality except for the proper knowledge of the functions and manipulation of the equipment It should be normally done by the same user of the equipment The operations to be carried out are as follows 5 1 1 CLEANING OF THE NEUMOTACHOMETER OR TURBINE TRANSDU CER A FLEISCH NEUMOTACHOMETER The neumotachometer is the most delicate part of the spirometer and therefore you must have special care in handling of the same Regard being had to the fact that the neumotachometer is the part exposed directly to the patient it is necessary to
10. 1 89 Fres wmMig 768 References SEPAR Motive Peocedence Techn Tranzduogn Onda Fleisch Date 3 18 1999 fgety 42 Hyht Ksa 92 Humid 75 I 20 Ethnic Fix 100 MANOEUVRE Ni 1 1 OBS 8 36 1 11 REF 5 1 10 PROCEDURE FOR THE MAXIMAL VOLUNTARY VENTILATION TEST MVV The procedure to perform the Maximal Voluntary Ventilation test MVV is similar to the described in point 1 8 PROCEDURE FOR THE FORCED VITAL CAPACITY TEST FVC with the following variations 1 Enter the MVV test and perform a manoeuvre MUU 8 1 gt REF 166 26 167 78 44 12 l min2 gt 274 The presentation of the axis is made VOLUME TIME mode incen tive is not available 3 The maximum time for performing the manoeuvre is 15 seconds They are put in order by the highest MVV 4 The record of parameters and graphics is the displayed next according to configuration It is not allowed to superpose the manoeuvres in mode VC as they will not give any complementary information 511 800 MU2 Rev 2 02 2013 10 DR JOHN SMITH SAINT PETER HOSPITAL PHEUMOLOGE DATOSPIR 126 SIBELMED Code 1254567098 CHARLES FOREST EF Bex Male Agety 43 176 MWyht Ra 92 Tenet my 25 Humid 75 Th Smk I a Refer
11. 2 02 2013 10 1 5 2 SET UP For the spirometer set up press the key Stop Start Next the LED indicator is lit the device emits sound and makes auto check For some seconds the logo SIBELMED is displayed on the screen as well as some other information like Version of the program Address of SIBEL S A Warnings of auto check Warnings of calibration if proceeds Warnings of maintenance if proceeds Next the MAIN MENU is displayed 18 23 1999 13 33 In the lower part of the screen the clock calendar with date and time is displayed It can be updated in the Maintenance Program The environmental values for Tem perature Pressure and Humidity are also presented if the corresponding Electric Weather Station is available 1 5 3 OBSERVATIONS ABOUT THE HANDLING OF THE DEVICE The spirometer development has been carried out prioritising its simple use so that the user can handle it easy and comfortably Maybe all the functions of the device seem complex but due to the conception of the device and its use the user will realise that the device is extremely easy and intuitive to use for anyone who works 511 800 MU2 Rev 2 02 0 in the health environment spirometer ETRY CONFIGURATION espir metro DATOSPIR med 1200 SPIROM 1 l A 4 lt P 6 n Ged Ged Ged ik am a um
12. BOQUILLA GOMA NEUMOTACOMETRO 03065 NEUMOTACHOMETER RUBBER MOUTHPIECE 1 e SOPORTE NEUMOTACOMETRO NEUMOTACHOMETER HOLDER 02224 1 CONEXI N CON PC PC CONNECTION LINK 02305 1 LICENCIA SOFTWARE ESPIROMETR A W 20 SPIROMETRY LICENSE SOFTWARE W 20 1 MANUAL DE USO Doc 511 8F0 MU1 USER MANUAL SOFTWARE W 20 Doc 511 8F0 MU2 NO INCLUIR EL CABLE CON LLAVE 02484 1 M DULO PIM PEM Compuesto por MEP MIP MODULE Including 07266 1 SONDA OBTURADORA PIM PEM MEP MIP SHUTTER PROBE 01566 1 BOQUILLA MULTIUSOS ADULTOS MULTIUSE ADULTS MOUTHPIECE 1 MANUAL DE USO ANEXO PIM PEM Doc 511 8D0 MU1 ANNEX MEP MIP USER MANUAL Doc 511 8D0 MU2 02446 1 SONDA SNIF PARA ADULTOS SNIF PROBE FOR ADULTS Requiere PLACA PIM PEM MIP MEP BOARD required 511 800 MU2 Rev 2 02 2013 10 RELACI N DE CONTENIDO PACKING LIST DATOSPIR 120 P gina 2 de 3 511 808 010 REV 2 01 2012 05 C DIGO CANT DESCRIPCI N A B C D CODE QTY DESCRIPTION 06998 1 MODULO SNIF Compuesto por SNIF MODULE Including 07266 1 e SONDA SNIF PARA ADULTOS SNIF PROBE FOR ADULTS 04108 1 PLACA PIM PEM MIP MEP BOARD 1 INTERCONEXI N PIM PEM MIP MEP CONNECTION 02487 1 M DULO PULSIOXIMETRIA Compuesto por PULSE OXIMETRY MODULE Including 01846 1 e SENSOR PULSIOXIMETRIA SPO PULSE OXIMETRY SPO SENSOR 1 e MANUAL DE USO ANEXO SPO Doc 511 890 MU1 ANN
13. Diagnosis Store test for Postbronchodilatation Store test in DataBase Test printing Slow Vital Capacity test VC Similar to FVC Maximal Voluntary Ventilation test MVV Similar to FVC POSTbronchodilatation test POST Similar to FVC 511 800 MU2 Rev 2 02 0 Bronchoconstriction test Test data Patient Environment Time between doses Type of medicine and dose Test method Abbreviated Normal or continuous Chronometer for time control Start of spirometric manoeuvre Graphic display Flow Volume Volume Time Dose Response Select manoeuvres Select best manoeuvre Test summary Store test in database Test printing Print a general report of tests performed to a patient 1 6 6 PULSE OXIMETRY PROGRAM See the Annex PULSE OXIMETRY if this option is included 1 6 7 MAXIMAL RESPIRATORY PRESSURES PROGRAM See the Annex MAXIMAL RESPIRATORY PRESSURES if this option is included 1 6 8 COMMUNICATIONS SYSTEM Transfer of patients tests Transfer of device check data Hardware check up Software check up Device configuration Calibrations record Software updating Export of tests to other management systems 511 800 MU2 Rev 2 02 2013 10 1 7 DEVICE CONFIGURATION The multiple variety of options included in the spirometer DATOSPIR 110 120 rec ommends that each user configures it according to his needs The different options in the Configuration Program will be detailed in point 1 6 2 To
14. 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 110 120 is used exceeds the applicable RF compliance level above DATOSPIR 110 120 should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such reorienting or relocating DATOSPIR 110 120 gt Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m 511 800 MU2 Rev 2 02 2013 10 Recommended separation distances between portable and mobile RF communications equipment and DATOSPIR 110 120 DATOSPIR 110 120 is intended for use in an electronic environment in which radiated RF disturbances are controlled The costumer or the user of DATOSPIR 110 120 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and DATOSPIR 110 120 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 tran
15. to the ATS ERS for one or for both parameters This criteria indicates that the best two observed values of FVC and the two best values of FEV1 must not differ in more than 0 2 litres and in this case the test can be considered as acceptable The different standards recommend performing at least three satisfactory manoeu vres where the reproducibility criteria is met Do not surpass the eight as this could mean the tiredness of the patient NOTE Remember that going back in the menu without losing the available information up to that moment is possible with the backspace F1 ESC ex cept if we change the patient entering a new code or in any other situation Anyway it is indicated on the screen 511 800 MU2 Rev 2 02 2013 10 1 8 3 DISPLAY OF THE RESULTS Press key F7 FEF253 TIA Best FUC Best FEU1 Marnin References When entering this option the results for the best manoeuvre Mare presented In order to see the values for another manoeuvre press the corresponding key M1 to M5 The screen presents Reference Observed values and between both selected in the Configuration Program It also presents the best values for FVC and FEV which can correspond to differ ent manoeuvres Values of Reference used Ethnic factor if it is not used it must be 100 Nonconformity warnings with the ATS ERS criteria for each manoeuvre The icons give access to F2 Deletes the
16. 47 1 71 2 81 F 3 22H 0 025A 1 60 1 35 2 22 MEF 50 FVC M 3 79H 0 031A 0 35 1 32 2 17 F 2 45H 0 025A 6 1 10 1 81 MEF 25 FVC M 2 61 0 026A 1 34 0 78 1 28 F 1 05H 0 025A 1 11 0 69 1 13 M Male F female H hight m A age years RSD Residual Standard Deviation Ages from 18 24 years are computed as 25 years for all references Between 6 and 18 years are taken the tables of the SEPAR unless others are indicated 511 800 MU2 Rev 2 02 2013 10 IMPORTANT ADVICE A ETHNIC FACTOR can be introduced in the DATOSPIR 110 120 Spirometer This factor modifies the reference values for different people groups and it can be in the range from 80 to 120 of the reference values being a 100 the value of the tables 4 5 OTHER REFERENCE VALUES AND AGE RANGE Aside SEPAR and CECA references the spirometer has also the following references ECCS ERS 7 to 70 For ages between 6 and 18 are used SEPAR values and for ages gt 70 reference values are extrapolated KNUDSON 6 to 84 For ages lt 6 amp gt 84 reference values are extrapolated CRAPO 4 to 91 For ages gt 91 reference values are extrapolated ZAPLETAL 4 to 17 years MORRIS 24 to 100 years AUSTRIA 6 to 90 For 4 years and ages gt 90 reference values extrapolated GUTIERREZ CHILE 5 to 100 For 4 years reference values are extrapolated BRAZIL 6 to 76 For ages lt 6 amp gt 76 reference values are extrapolated
17. Device Directive 93 42 EEC According to this directive the device is Class lla It also applies the standards of Electric Safety EN 60601 1 IEC 601 1 UNE 20 613 1 and the Electromagnetic Compatibility standards EN 60601 1 2 and EN 55011 Group Class B 1 2 PREVIEW OBSERVATIONS This User Manual is oriented to all the models and options which can com pose the spirometer DATOSPIR 110 120 In each case only the corresponding options or functions of the available model will be applied This spirometer is manufactured with professional solid components under strict quality controls Nevertheless accidents might happen in the transportation or storage of the devices It is convenient to make an initial check up of its condition before installing it as well as of its accessories 511 800 MU2 Rev 2 02 2013 10 WARNING IFANY DAMAGE IN THE PACKAGING IS DETECTED CONTACT IMMEDIATELY WITH THE TRANSPORT AGENCY AND YOUR DISTRIBUTOR BEFORE IN STALLING IT DO NOT THROW AWAY THE PACKAGING BAGS ETC UNTIL THE CORRECT FUCTIONING OF THE DEVICE IS VERIFIED 1 33 MODELS OF SPIROMETER DATOSPIR 110 120 The DATOSPIR 110 120 spirometer series consist of different models depending on the options incorporated DATOSPIR 120 A DATOSPIR 110 A DATOSPIR 120 B DATOSPIR 110 C DATOSPIR 120 C DATOSPIR 120 D The enclosed tables show the basic characteristics included in each model as a stan dard and the other parts or functions that can be incl
18. EN 55011 Class B very low and are not likely to cause any interference in nearby electronic equipment RF Conducted emissions Grupo 1 DATOSPIR 110 120 uses RF energy only for its internal function Therefore its RF emissions are CISPR 11 EN 55011 Clase B very low and are not likely to cause any interference in nearby electronic equipment Harmonic emissions Class EN IEC 61000 3 2 Voltage fluctuations Flicker Yes emissions EN IEC 61000 3 3 511 800 MU2 Rev 2 02 0 Guidance and manufacturer s declaration electromagnetic immunity DATOSPIR 110 120 is intended for use in the electromagnetic environment specified below The costumer or the user of DATOSPIR 110 120 should assure that it is used in such an environment Immunity test Electrostatic discharge ESD EN IEC 61000 4 2 Electrical fast transient burst EN IEC 61000 4 4 Surge EN IEC 61000 4 5 EN IEC 60601 test level 6 kV contact 8 KV air 2 kV for power supply lines 1 kV for input output lines 1 kV differential 2 kV common mode Compliance level 6 kV contact 8 KV air 2 kV for power supply lines 1 kV for input output lines 1 kV differential 2 kV common mode Electromagnetic environment Guidance Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Mains power quality should be that
19. F5 3 Enter the password 120 4 Copy the new file provided by SIBEL containing the update D12 tsk to the FIRMWARE directory of the application W20 5 Runthe W 20 Spirometry Software access the Configuration Links option and check that Datospir 110 120 is selected 6 Access the Configuration Utilities Update Flash option the W 20 Spirometry Software in demo mode provided on purchasing the equipment is enough A dialogue 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 7 The new programme will be transmitted The process may take around 10 minutes depending on the PC 8 Switch off the DATOSPIR 110 120 1 16 3 PATIENT TESTS MANAGEMENT IN THE PC Ifyou want to display print manage and or store the tests in the PC it is necessary to have the SPIROMETRY SOFTWARE W 20 The process to follow is 1 Store the tests in the internal database of the device 2 Set up the SPIROMETRY SOFTWARE W 20 as detailed in the Software W 20 Use Manual 3 Load the Database data from the PC using the W 20 Software BATCH option 4 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 5 Thescreen displays a list with the tests transferred The ones to be imported to the PC DataBase are selected in the option
20. If it is a Disposable Transducer when a PREbronchodilatation manoeuvre is stored it stores also the calibration factor so it can be used later on the POSTbronchodilatation test if wanted so C Memorisation of a test in the Internal DataBase This option stores the test in the Internal DataBase of the device to display it print it and or transfer it to a computer Proceed as in previous point but through key F8 1 8 6 OTHER SPIROMETRIC TESTS TO THE SAME PATIENT After performing the FVC test to a patient it is possible to make the following spiro metric test to the same patient A VC test A MVV test A Postbronchodilatation test A Bronchoconstriction test It is also possible to Print the general report of all the tests of the same patient Start the process of tests with other patient The spirometer stores automatically the best manoeuvre for each test of FVC VC MVV and or POSTbronchodilatation in order to print if preferred a general report with all the test before going to another patient Go back to the screen shown and select the option 16 25 1999 12 39 511 800 MU2 Rev 2 02 2013 10 F2 New patient POSTbronchodilation test or Bronquial Provocation F5 Forced Vital Capacity test F6 Slow Vital Capacity test F7 Maximal Voluntary Ventilation test F8 General report 1 8 7 CHANGE OF PATIENT To change the patient press key F2 on t
21. MAINTENANCE To ensure vital safety features under the EN 60601 1 standard only equipment compliant with the electrical safety standards in force may be connected to this device To connect DATOSPIR 110 120 to a non medical device with ground conductor you must install an additional ground conductor to the non medical device DO NOT use multiple mains sockets unless they comply with EN 60601 1 They can degrade electrical safety DO NOT submerge the transducers connectors in any liquid THIS CAN RESULT IN ELECTRICAL DISCHARGE EXPLOSION RISKS DO NOT uses the device in presence of anaesthetics or flammable gases IT CAN RESULT IN EXPLOSION RISKS OF CONTAMINATION To avoid the risk of contamination or cross infection the Turbine and Fleisch transducers must be cleaned disinfected before use Consult the section UPKEEP PREVENTIVE AND CORRECTIVE MAINTENANCE Reusable mouthpieces must also be disinfected Disposable transducers and disposable mouthpieces must not be reused 511 800 MU2 Rev 2 02 2013 10 RISKS OF INTERFERENCE This is an electronic product so high frequency emissions can interfere with thecorrectuse Forthisreason the products which can generate interferences radios cellular phones etc should be kept apart The portable or mobile radiofrequency devices can affect the normal functioning of the electronic medical devices This is a medical electronic device and as such it needs special precautions re
22. Make sure that the neumotachometer is at room temperature If not wait for some minutes or cool it up with air 5 Press key F5 of the previous screen and start the process of calibration emptying out the syringe for two or more consecutive cycles a cycle is the emptying plus the filling of the syringe The piston of the syringe must move in the emptying and in the filling the total volume taken as a reference If this is not made properly the device will detect it as incorrect manoeuvres Moreover it is convenient to make this process regular and uniformly without causing too high or low flows The time of each cycle must not be less than three seconds or more than six 6 The screen shows the expiratory and inspiratory factors taken by the device If they are inside the 2 it will show that the system is calibrated Otherwise repeat point 5 7 Once the calibration is finished quit the Calibration Program and enter the Spirometry Program to start the tests Note If when introducing the calibration parameters in point 3 the Calibration volume 0 is assigned the system takes the calibration factors F EXP and F INS 1 00 corresponding to the original manufacturer calibration It is con venient to use this calibration only as orientative if a syringe is not available 511 800 MU2 Rev 2 02 2013 10 1 13 4 CALIBRATIONS RECORD The spirometer has a record with the expiratory and inspiratory factors
23. Reference Ventilatory alteration of No Obstructive type FVC lt 80 Light FVC lt 65 Moderate FVC lt 50 Strong FVC lt 35 Very Strong If FEV1 FVC gt FEV1 FVC Reference 511 800 MU2 Rev 2 02 2013 10 and FVC gt 80 of FVC Reference A ventilatory alteration of mixed type is suspected If FEV1 FVC lt FEV1 FVC Reference y FEV1 gt 80 of FEV1 Reference A ventilatory alteration of mixed type is suspected If a POSTbronchodilatation test is performed And the FEV1 POST is over 15 to the FEV1 basal or PRE There is a positive response to the bronchodilator drug NOTE THE SPECIALIST ALWAYS MUST VALIDATE THE DIAGNOSIS AND THE RE SULTS OF THE TEST 1 8 5 PRINTING AND OR MEMORISATION OF THE FVC TESTS After performing at least one manoeuvre any of these operations can be done A Printing of the results Once the corresponding manoeuvres are performed press F7 on the data screen or F8 on the graphic screen and the following display will appear 511 800 MU2 Rev 2 02 0 DR JOHN SMITH SAINT PETER HOSPITAL PNELIMOLOGY DATOGPIR 126 SIBELHED Coda 1234567890 Date 38 18 1999 CHARLES FORESTER Sexi Male figu 1 a3 6 Wght Kg 92 Tewpt 85 Humid 4 79 Pres meHg 760 Sp I 2B References SEPAR Fthnie Motive Procedence Techn Transducer Fleisch REPORT MANOELWRE 2 2 PARAMETER OBS REF ivi Best FUC 1 5 44 5 25 4 Best FAVA
24. Software Set up W 20 6 Fromthatmoment you can select display or print any imported or transferred tests to the PC 511 800 MU2 Rev 2 02 2013 10 1 16 4 EXPORT OF TESTS TO OTHER SYSTEMS The spirometer DATOSPIR 110 120 has the possibility to export previously stored tests in the Internal DataBase to other management systems of each particular hospitalary centre The device presents the information in mode delimited by inverted comas which makes it compatible with multiple systems This export of tests is carried out in a similar way to the described in point 1 16 1 The information is available in the following files PRUEBAS TXT contains the database tests GRAFICAS TXT contains the graphics in mode Flow Time The graphic file as indicated contains graphics for each test in mode Flow Time If you want to display the graphics in the new management system in mode Vol ume Time or Flow Volume the following aspects have to be take into account With the turbine transducer the Flow signal is sampled at 25Hz and with the Fleisch or disposable transducers at 100Hz In the Volume Time graphic the relation of the axis must be adjusted at 1 litre 2 seconds In the Flow Volume graphic the relation of the axis must be adjusted at 2 1 5 1 If there is any doubt or consult contact with the Technical Service of SIBEL S A or your distributor who will explain the information you require 1 17 SPIROMETRY SOFTWARE
25. Start a new selection of forced manoeuvres once the normalised time has passed 511 800 MU2 Rev 2 02 2013 10 The manoeuvres are compared to the stored basal F3 Gives access to the display of the data F4 Presents a summary with the data of the performed steps After the adequate manoeuvres are performed press F3 to display the data and again F8 to store the best manoeuvre and go to the next step 3rd Step CONSTRIC BC1 COHMSTRICTIOM TEST 4 74 3 28 3 56 82 91 82 14 1 7 08 3 56 Ethnic Ft 169 References SEPAR Modify the data if necessary Apply the first dose of bronchoconstrictor drug and press F7 Start another series of manoeuvres again F2 the chronometer to control the start of the manoeuvre after the application of the drug It also blocks the acoustic alarm of the chronometer F7 Presents the graphic dose response of the performed steps F8 Enables to display or modify the medicine dose Store the best manoeuvre in a similar way to the previous steps 4th Step CONSTRIC BC2 BC3 BC9 The same procedure as in the previous step but for the second third tenth dose as they are necessary When the FEV1 value drops under 20 regarding the diluent or the basal if the diluent has not been made the system warns about it and the graphic dose re sponse shows the value for PD20 MU2 Rev 2 1 2 2013 10 11 8 C gt
26. W 20 FOR PC For the information related with the Software W 20 Optional see the Soft ware User s Manual 511 800 MU2 Rev 2 02 0 511 800 MU2 Rev 2 02 2013 10 511 800 MU2 Rev 2 02 2013 10 2 2 TECHNICAL SPECIFICATIONS The specifications detailed below should apply according to the model that the user has These models are detailed in the paragraph 1 3 MODELS OF SPIROMETER DATOSPIR 110 120 2 1 TYPES OF TESTS FUNCTIONS AND SPIROMETRIC PARAMETERS 2 1 1 FVC FORCED VITAL CAPACITY Parameters FVC FEV 5 FEV1 FEV3 FEV 5 FVC FEV1 FVC FEV3 FVC FEV1 VC PEF MEF75 MEF50 MEF25 FEF25 75 FEF75 85 FET25 75 0 MEF50 MIF50 FEV1 FEV 5 FEV1 PEF MIF50 FIVC FIV1 FIV1 FIVC FEV1 FIV1 PIF MTT PEF PIF Vext MVVin FEV6 FEV1 FEV6 I s s 1 Forced Vital Capacity Forced Expiratory Volume in 0 5 seconds Idem in 1 second Idem in 3 seconds Relation Relation Relation Relation Peak Expiratory Flow Maximal Expiratory Flow when the 75 of FVC remains in the lung Idem at 50 of FVC Idem at 25 of FVC Forced mid expiratory flow Forced mid expiratory flow between 75 85 of FV C Forced expiratory time between 25 75 of FVC Forced Expiratory Time Relation Relation Relation Maximal inspiratory flow when the 50 of FVC has been inspired Forced Inspiratory Vital Capacity Forced In
27. criteria in the different standards Next there is a short description of the different steps taking part in this type of test from the point of view of the device use The steps described are not the only possible although the most accepted ones The spirometer DATOSPIR 110 120 has the possibility to perform the test accord ing to two different methods Normal or continuous method Consists of applying the patient a certain concentration for a specified time Abbreviated method Consists of applying the patient a certain number of inhalations of a certain concentration The procedure in both cases is the same The variation lies in the way of applying the drug In the first case the patient breaths the concentration for a while and in the second case we apply the inhalations to make it quicker The steps of the test are 15 BASAL BAS Perform a basal spirometry 2 DILUENT DIS Apply a diluent with neutral PH to the patient if convenient and perform a 511 800 MU2 Rev 2 02 2013 10 spirometry that compares to the basal 34 CONSTRIC BC1 Apply the patient the first dose of bronchoconstrictor drug and after the stipu lated time perform the spirometry It is compared to the DILUENT DIS or to the BASAL BAS if the diluent has not been made Go to the next step to continue with the test 4 CONSTRIC BC2 The same as the last step but with the second dose of drug 5 CONSTRIC BC3 The same as th
28. deviation regarding the reference values Normalised reference values to be selected between several standards Data for patient identification Environmental data of temperature pressure and relative humidity Graphics in VOLUME TIME 5 manoeuvres of the same test can be stored 2 1 3 MAXIMUM VOLUNTARY VENTILATION Parameters MVV Br min l min Maximum Voluntary Ventilation Br min MVV Breathing Rate Percentage of deviation regarding reference values Normalised reference values available between several standards 511 800 MU2 Rev 2 02 2013 10 Data of patient identification Environmental data of temperature pressure and relative humidity Graphics in VOLUME TIME mode 5 manoeuvres of the same test can be stored 2 1 4 BRONCHODILATATION TEST The same parameters as in the FVC Some comparison methods between PRE POST and REF values Superposition of graphics PRE and POST 2 1 5 BRONCHOCONSTRICTION TEST Parameters FVC Forced Vital Capacity FEV1 Idem in 1 second PEF 1 5 Peak Expiratory Flow FEF25 75 I s forced mid expiratory Flow Data of Patient identification Environmental data of temperature pressure and relative humidity Continuous or shorter methods Deviation Percentage between Basal and dissolution Superposition of graphics in FLOW VOLUME or VOLUME TIME Stopwatch for controlling the steps Type of drug and accumulated dose Calcul
29. enter this program press key F2 in the Main Menu COPIF I GURAT TOM 18 25 1999 12 08 F1 ESC escapes from this screen and returns to the previous F2 Pattern Setup 5 Common Configuration F6 Spirometry Configuration F7 Pulse oximetry Configuration F8 Configuration of Maximal Respiratory Pressures 1 7 1 PATTERN CONFIGURATION This option consists of the memorisation of a status defined by the user of the con figuration program in order to restore it at any moment global and automatically This option allows restoring the configuration if it has been modified by any voluntary or involuntary circumstance In general this set up is the most commonly used 511 800 MU2 Rev 2 02 2013 10 PATTERN CONFIGURATION 18 25 1999 12 03 F2 Restores the Pattern Set up F3 Records the Pattern Set up To record the pattern Set up follow these instructions 1 Configure each option Common Configuration Spirometry Configuration Pulse oximetry Configuration Maximal Respiratory Pressures Configuration as detailed below 27 Return to the Pattern Set up and press key 34 From this moment your Pattern Set up is memorised If you need to modify any configuration option during a test performance you can enter manually and modify it The Pattern Set up can be restored at any moment 511 800 MU2 Rev 2 02 2013 10 1 7 2 COMMON CONFIGURATION In this option you can configure some common sub options for any tes
30. is codified in instructions that compounds the program The CPU used is the HITACHI s H8 532 microcontroller 3 8 5 CONTROLLERS They transfer information between the CPU and the rest of devices as the keyboard display and printer They are integrated in the circuit of the microcontroller with the exception of the serial communications interface and the display controller 3 8 6 QUALITATIVE DESCRIPTION The control program is the responsible for the treatment of the spirometry signal meet the requirements of the standards taking especially care of calculation of Determination of start of expiration The start of test is determined by surpassing a flow threshold of approximately 100ml s but the values recorded before are not discarded Retrograde extrapolation The determination of start of FVC manoeuvre is performed by a retrograde extrapo lation as A T S and S E P A R criteria Determination of end of manoeuvre The end of FVC manoeuvre is carried out following A T S criteria that means the accumulated volume in the last second is less than 25ml Calibration program Turbine The posible aging or the accumulated dirt of the turbine transducer may do an inac curate measure To checkthe turbine measures properly the system includes a simple check up procedure based in measuring the known volume of a calibration syringe 511 800 MU2 Rev 2 02 2013 10 Neumotachometers The relationship between the pressure drop and
31. is not any caughing or Valsalva operation due to glottis closing Special attention must also be paid to avoiding excesively early ending of expiration which would be detected at the end of the curve This would reach too perpendicularly the horizontal base line Sometimes the patient inadvertenly partially blocks the mouthpiece with his tounge or his false teeth 511 800 MU2 Rev 2 02 2013 10 As an essential criterion the two best expirations out of the three best acceptable curves can differ between them up to 5 or 100 ml in the FVC wichever is greater The best effort cannot be determined only by simple inspection of the spirometric curve Measurements must be checked in order to determine the maximum values The independent selection of FVC and FEV1 sometimes provokes a slight increase of variability since factors such as learning fatigue or bronchospasm come into play induced by the expiration It is not necessary to discard the best FEV1 when the operation it comes from has finished permaturely On the other hand the FEF25 75 is influenced by the selected curve vital capacity Mistaken high values may result if an operation with trim vital capacity minor than the individual s actual one has been selected Aparently the most practical way to carry out its calculation is by choosing the operation containing the maximum Vital Capacity and FEV1 add among the three selected 4 2 CALIBRATIONS Apart from the calibration
32. maintain it in perfect physical and hygienical con ditions To this purpose proceed as follows 1 Take off the rubber nozzles and extract the linealizing cones Fig 5 1 1 LINEARIZED a 2 LAMINATOR RUBBER MOUTHPIECES PNEUMOTACHOMETER BODY Fig 5 1 511 800 MU2 Rev 2 02 2013 10 2 Extract the laminator turning to the left and taking it out as shown in Fig 5 1 1 3 Wash the rubber nozzles cones and laminator with soap Regard being had to the structure of the laminator the procedure must be very careful 4 After rinsing it is convenient to rinse again with destilled water to avoid deposits of salts especially on the flux laminator 5 The final drying is carried out with a simple electric dryer such as those employed for hair drying which allows to considerably accelerate the process Procure that the laminator is not exposed to temperatures of more than 70 C For this reason put the dryer not nearer to the laminator than 15 or 20 cm and do not keep it during a long time 6 Clean internal and external parts of neumotachometer with a dry or slightly water moistened cloth drying thereafter the remanent humidity You must pay special attention to that no liquid penetrates inside nor to the connectors or con nections See fig 5 1 2 Don t use abrasive substances or solvents PRESSURE INLETS Fig 5 2 Fig 5 3 If you suspect a microbian contamination it is necessary
33. obstruction or resistor to the airflow made of a grid In this neumotachometer the airflow is turbulent so the relationship between flow and pressure is quadratic not linear Pressure constant1 x FLOW constant2 x FLOW In this case linearizing by software is a must in a more complex way than a Fleisch transducer Nevertheless its simplicity allows building a cheaper neumotachometer and also a disposable unit 3 5 DIFFERENCIAL MANOMETER The Fleisch and Lilly neumotachometers transform the airflow in a pressure drop The next step is to convert the pressure drop in electrical signal To do this a differ ential manometer is used The type of the pressure transducers that are included 511 800 MU2 Rev 2 02 0 in Fleisch and Lilly neumotachometers of DATOSPIR 120 is semiconductor with internal temperature compensation 3 6 FILTERS AND AMPLIFIERS The analogue signal which the neumotachometer pressure transducer gives shuold be conditioned before being digitalized and processed This conditioning stage has an amplifier that adapts the range of the transducer to the range of the digitalizer and a filter that reduces the unwanted noise This filter limits the bandpass from 0 to 15 Hz 3 7 ANALOGIDIGITAL CONVERTER The analogue to digital converter samples the analogue signal when the processor orders it and quantifies the value at its input in this case the pressure transducer signal giving at its output a numeric digital word
34. of the last performed calibrations This is useful for those centres that require a quality con trol of the used processes For this purpose press F2 on the first screen of the calibration process CALIBRATIGONE REGISTER D BB 99 38 99 10 63 49 36 08 31 99 18 25 1999 16 28 F2 Deletes a record F7 Prints the existent records The displayed information is Number of available records Date of calibration Time of calibration Volume of calibration Expiratory factor Inspiratory factor 511 800 MU2 Rev 2 02 0 1 14 INTERNAL DATABASE The DATOSPIR 110 120 has an Internal DataBase standard or optional depending on model to store the different tests performed with the device Then it enables to display print and or transfer the tests to a PC or other computer systems for storage or management The information of the base is kept although the device is disconnected from the mains There are two databases with the same functions but different capacities DataBase L DataBase H The tests to be stored taking a six second FVC as reference are With graphics Without graphics Fleisch Disposable Tur bine Fleisch Disposable turbine DataBase L 150 150 150 DataBase H 400 900 1500 The test storage has been described in the corresponding points for each test From the Main Menu screen press F1 DATA BASE 11 26 1999 F5 Displays the s
35. or functioning mode Normal mode Short mode Select if diluent is going to be used Define the time between the application of the bronchoconstrictor drug and the start of the manoeuvres 511 800 MU2 Rev 2 02 2013 10 Define the time between the application of bronchodilator drug and the start of the manoeuvres Enter the initial dose of the bronchoconstrictor drug in mg ml Register the bronchoconstrictor drug Register the bronchodilator drug Once the previous data are filled in press F7 key 1 12 3 PROCESS OF THE TEST As commented above the Brochoconstriction test is based on performing forced spirometries after the application of different doses of drugs and controlling the drop of FEV1 The steps for the test are the following 1st Step BASAL BAS Start the process of forced manoeuvres as described in point 1 8 2 INPUT OF FORCED VITAL CAPACITY TESTS FVC 0 eo MU2 Rev 2 02 2013 10 Fae FIUC Ix a h 4 3 d 3 6 4 4 34 4 24 12 3 56 3 28 111 Ethnic The manoeuvres are compared to the values of the patient Reference F2 Deletes the selected manoeuvre F8 Stores the best manoeuvre and goes to the next step Press F8 to store the manoeuvre and go to the next one 2nd Step DILUENT DIS Apply the diluent with neutral PH to the patient if you have selected this option
36. pressure transducer 3 1 TURBINE The turbine type is axial with two helix shape stators and a rotor made with a rec tangular plane blade The physical shape of the stators makes the airflow that cross the turbine turns This spin is the responsible that the blade turns The functioning of the turbine is based in the Fluid Mechanics especially in the Turbo machine theory Applying this theory the angle that the rotor turns is directly proportional to the fluid volume that crosses the turbine and the proportion constant depends on the physical shape of the turbine 3 2 TURBINE TURN DETECTOR The turbine turn detector has three pairs of emitter diode and phototransistor of infrared light invisible that are located conveniently to detect the rotor turns and its direction The beam interruption number is equal to the accumulated angle of rotor turning and therefore the volume that has crossed the turbine The phototransistor gives a digital electrical signal that is directly acquired by the microprocessor 3 3 FLEISCH NEUMOTACHOMETER The Fleisch neumotachometer principle is based in measuring the pressure drop obtained between the extremes of an obstruction which permits the air passes in a quasi capillar mode Applying then the Poiseuille law la relationship between the flow and pressure is linear 511 800 MU2 Rev 2 02 2013 10 PRESSURE constant x FLOW In the Fleisch neumotachometer multiple capillar tubes make the ob
37. procedures incorporated to the unit by the manufacturer for a quick checking of the running of circuits and basic machinery of the pneumo tachometer the unit should admit check out by means of applying external signals These signals must bear the maximum similarity to the biological sign for which the instruments have been designed i e forced expiration This is not always possible but al least some ofthe biological signal elements such as volume and flow should be reproduced either together or separately For this purpose syringes with several litres capacity provide a suitable signal and flow generators are good for valuating the accuracy and errors in the flow measurament The so called explosive descom pressor is one of the most practical calibration machines It consists of a chamber of 4 or 5 litres pressured at 1 athmosphera provided with sudden oppening for the violent expulsion of a volume identical to the one inside the chamber In this way an individual s forced expiration can be simulated By placing suitable resistances with different obstruction rate in the exit tube the signal is similar to that of a patient with slight moderate or severe obstruction to air flow Therefore it checks both the volume and the flow measurements Building a ma chine of these characteristics is easy but if you cannot build one you can check the machine operating conditions by means of using control individuals that is to say people connected
38. selected manoeuvre F3 Presents the diagnosis based in the selected manoeuvre F4 Stores the selected manoeuvre in order to compare it with the test POSTBRONCODILATION if this is going to be performed F5 F6 Displays the rest of parameters if they are selected F7 Prints the report of the selected manoeuvre F8 Stores the selected manoeuvre in the INTERNAL DATABASE WARNING As previously mentioned the BEST manoeuvre is placed in M1 Therefore in order to present the diagnosis print the report or store the manoeuvre for the POSTbronchodilatation or for the Internal Data the M1 must be used except if the user prefers to use another one 1 8 4 TYPE OF DIAGNOSIS The spirometer DATOSPIR 110 120 has two types of diagnosis to select in the Configuration Program A Miller diagnosis Presents the following information NORMAL RESTRICTIVE OBSTRUCTIVE or COMBINED according to the criteria of the following quadrant da 66 160128 FUC FUCPef B Snider Kory amp Lyons diagnosis It is based on the following criteria If FVC gt 80 of FVC Reference and FEV1 gt 80 of FEV1 Reference Values in the reference range Normal Diagnosis If FEV1 FVC lt Reference FEV1 FVC FEV1 lt 80 of FEV1 Reference Ventilatory Alteration of Obstructive type FEV1 lt 80 Light FEV1 lt 65 Moderate FEV1 lt 50 Strong FEV1 lt 35 Very strong If FEV1 FVC gt FEV1 FVC Reference and FVC lt 80 of FVC
39. the airflow in the neumotachom eters depends on the gas viscosity This viscosity is also depending of atmospheric conditions of temperature pressure and humidity This is the reason for calibrating the neumotachometer every day or every time that atmospheric conditions change Analysing the relative importance of the factors the main factor is temperature followed by humidity 511 800 MU2 Rev 2 02 2013 10 511 800 MU2 Rev 2 02 2013 10 4 SPIROMETRY TECHNIQUE 4 1 PROCEDURE The following is an extract from NORMATIVA PARA LA ESPIROMETRIA FOR ZADA FORCED SPIROMETRY REGULATIONS SEPAR recommendations 1 Forced spirometry must be carried out by the patient sitting bolt upright having his nose blocked by nasal tweezers The technician must lean his hand against the patient s shoulder to prevent the patient leaning forward during expiration time The mouthpiece must be deformation proof in order to avoid artefacts caused by the reduction of light due to bite during forced expiration Soft mouthpieces must be shortened in order to increase its consistency The spirometry will always involve a minimum of three forced expiration operations and a maximum of eight if they are not considered suitable Surpassing this limit will mean pointless patient tiredness and a loss of time for the technician For the evaluation of the spirometry carried out in decubitus position you must bear in mind that under these condi
40. this manual all the reports are made with wider paper To load the paper in the printer follow the next detailed instructions 15 Open the paper cover 2 4 Lift the lever that unlocks the pull cylinder 3 4 Put the paper roll as shown in the picture 4 Align the paper with the printer inlet and press F5 to feed the paper Take out some centimetres of paper put down the header lever and close the cover passing the paper through the slot 511 800 MU2 Rev 2 02 2013 10 6th Press F1 to go back to previous screen The paper cut is made pulling it forwards as shown in the picture 511 800 MU2 Rev 2 02 2013 10 External printer can be connected to all the models standard or optionally if the external printer has been selected previously in the Configuration option In this case follow the instructions of the corresponding printer 1 6 TREE OF FUNCTIONS OF THE SPIROMETER For a better understanding of the structure of the spirometer DATOSPIR 110 120 the spirometer functions tree is presented This structure corresponds to the most complete model with all the available options From the Main Menu we can enter depending to the included options to DATABASE PROGRAM CONFIGURATION PROGRAM CALIBRATION PROGRAM MAINTENANCE PROGRAM SPIROMETRY PROGRAM PULSE OXIMETRY PROGRAM MAXIMALRESPIRATORY PRESSURES PROGRAM It also includes a COMMUNICATIONS SYSTEM that allows the transfer
41. with the laboratory who are willing to cooperate They can carry out a correct expirometry easily and with little variability chart 1 in such a way that they can reproduce their expirometry periodically and compare it to previous data In this way errors that are necessa rily of a large magnitude can be detected The espirometry variability prevents the detection of small differences in volume and flow measurement see chart l 511 800 MU2 Rev 2 02 2013 10 In normal working conditions calibration by means of volume signal provided by a hand syringe should be carried out daily The signal provided by the syringe should be produced with different thrusts in order to verify that the flow read out maintains a rectilinear response since the machine must integrate the signal always in the same volume i e the one provided by the syringe signal How sudden the injecting operation may be does not matter as long as it does not surpasses the upper limit of flow rank accurately measured by the machine itself proximity to actual value The calibration with dinamic gauged signal provided by the explosive decompressor or spirometry measurement in control individuals cannot be carried out so often As for tachometers it is advisable to carry it out once a fortnight with the decompressor As spirometries with control individuals are more complicated and less available it cannot be carried out more often than once a month unless you have suspicio
42. 0 2 8 SIMBOLOGY SERIAL NUMBER MANUFACTURER The date of manufacture name and address of manufacturer TEMPERATURE LIMITATION HUMIDITY LIMITATION PREASURE LIMITATION DIRECTIONS FOR US APPLICABLE PART B LOT EXPIRY DATE CAUTION LAND STANDBY DISPOSAL OF WASTE ELECTRICAL ELECTRONIC AGREEMENT TO THE WEE DIRECTIVE DO NOT REUSE eim gt 18 gt p O E 511 800 MU2 Rev 2 02 2013 10 511 800 MU2 Rev 2 02 2013 10 3 FUNCTIONING PRINCIPLES The DATOSPIR 110 120 spirometer is an acquisition device for physical signals and a signal processor that gives information about the lung function To perform the signal processing is necessary to change the physical magnitude to electrical The units that perform this change are called transducers The DATOSPIR 110 120 has three different transducers a Turbine b Fleisch Neumotachometer and c Disposable Lilly Neumotachometer The turbine transducer performs its function in two steps The volume passes through the turbine and the rotor turns proportionally to the volume The rotor turns are detected by the interruption of a infrared light beam which sensor converts the light received in digital electrical signal The transducer function in the Fleisch and Lilly neumotachometers is also performed in two steps The airflow that passes through the neumotachometer produces a pressure drop that it is converted to an electrical signal by means of a
43. 13 10 WARNING According to different standards and specially the Medical Device Directive 93 42 ECC it is advisable to verify and or calibrate the electromedical devices periodically in order to guarantee the reliability of their functions and the safety of the patient user and environment The spirometer DATOSPIR 110 120 must have done besides routine calibra tions a general check up of its safety systems adjustments functions etc with a yearly periodicity Do not pass in any case more than eighteen months without doing it The check up must be done at any moment when the incor rect functioning of the device is suspected These check ups must be done according to the Verifying and Adjustment Manufacturer Procedures SIBEL S A by the manufacturer or qualified tech nical staff and authorised by SIBEL S A The accessories spare parts etc must be the original ones and they will be ordered to the manufacturer or authorise ddistributor so as to guarantee the correct functioning of the spirometer MANUFACTURER RESPONSIBILITY SIBEL S A is responsible for the safety reliability and functioning of this device only if The place where the device is installed meets the requirements of elec trical installation IEC as well as the rest of standards applicable if it is connected to the mains The reparations checks or modifications during the guarantee period or not are carried out by the technical staff of SIBEL S A
44. 4 44 4 04 FUC 5 24 dias FEV as 4 26 4 04 16 FEUMI FUC 81 20 77 48 105 PEF ifs 8 26 3 96 83 i l s 4 33 4 99 87 FEFR5y 75Z l s 4 04 3 88 s 4 89 0 69 0 66 4 FEUML PER 2 3 58 5 84 129 MI FSG l s 8 FIVE a 4 Comments a ERO Y VY va Y x 18 1415 jm 8 6 4 a 2 4 5 E 8 E44 NAI IO no 4n 511 800 MU2 Rev 2 02 2013 10 MILLER S QUADRANT X mm Combined 20 40 68 1 120 Fuc FUCref The report presents the parameters of the selected manoeuvre plus the best values for FVC and FEV1 among all the available manoeuvres The parameters graphics diagnosis and other information of the report can be adapted to the user s needs through the Configuration Program Remember that a general report or a set of tests FVC VC and MVV can also be made as specified at the beginning of point 1 8 B Memorisation of a test to compare it in POSTbronchodilatation mode This option enables to store a test in PREbronchodilatation mode to compare it to the POSTbronchodilatation mode Enter the data screen and select the manoeuvre to be memorised usually M1 Next press F4 to save it If a test has been memorised incorrectly select the correct one and proceed again This new information will replace the previous one 511 800 MU2 Rev 2 02 0
45. 72 0 530 0 0454T 0 0211E 2 83 0 75 0 403 0 0499T 0 0211E 3 84 0 75 0 444 0 0317T 0 0250E 1 23 0 82 0 307 0 1902E 85 58 0 224E 0 1126P 94 88 0 0392T 0 0430E 1 16 0 55 1 000 0 0230T 0 0456E 1 11 0 70 0 680 0 0945T 0 0209E 5 77 0 47 1 470 0 0488T 0 0304E 0 35 0 47 1 040 0 0517T 0 0397E 2 40 0 47 1 300 0 0242T 0 0418E 1 62 0 56 0 925 0 0190T 0 0356E 0 14 0 63 0 620 0 02T 0 031E 0 0062P 0 21 0 76 0 405 6 64 7 77 1 45 1 50 0 66 0 88 1 39 1 42 0 80 0 89 T T lt T lt T lt T T T lt T 511 800 MU2 Rev 2 02 0 M Male F female R multiple correlation coefficient SEE typical error of the estimation T size cm P weight Kg E age years The parameters with an asterisk are not related in the reference standard of the SEPAR 4 4 REFERENCE VALUES FOR FORCED SPIROMETRY ERS 93 Standardized Lung Function Testing Official Statement of the European Respira tory Society Luxembourg 1993 Variable Sex Ecuation 18 70 years RSD 164RSD FVC M 5 76 0 026A 4 34 0 61 1 00 F 4 43H 0 026A 2 89 0 43 0 71 FEV1 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 87 21 7 17 11 80 F 0 19A 89 10 6 51 10 70 FEF 25 75 1 94H 0 043A 0 1 04 1 71 F 1 25H 0 034A 2 92 0 85 1 40 PEF M 6 14 0 043A 5 1 21 1 99 F 5 50H 0 030A 1 11 0 90 1 48 MEF 75 FVC M 5 46H 0 029 0
46. ACHOMETER TURBINE PNEUMTACHOMETER CALIBRATION SYRINGE DISPOSABLE HOSE RECORDER SYRINGE TRANSDUCER CALIBRATION ADAPTER CALIBRATION SYRINGE 2 From the Main Menu screen press F3 key 511 800 MU2 Rev 2 02 2013 10 CALI BRAT I OM 9 UOLUMENM TEMPERATURE 25 REL HUM ATM PRESSURE LAST CALIBRATION ESP F 1 080 IHSP F 1 8060 DATE 16 26 1999 18 26 1999 18 3 F2 Record of last calibrations F3 Deletes a field or character according to situation F5 y F6 Takes back the cursor to the previous field or takes it forward to the following field F7 Validates the entered data and goes to next screen 3 Fill in the data of the screen according to Date automatically taken Calibration volume 1 Volume in litres of the syringe to be used between 1 and 6 litres No of pulses Only in the case of turbine Number printed in the turbine corresponding to the number of pulses turn Temperature C Value of the room temperature in C Humidity Idem of the relative humidity in Pressure mmHg Idem of the environmental pressure in mmHg Operator Name or code of the person performing the calibration if wanted The data of the last calibration expiratory and inspiratory factor and date are not modifiable It presents the data available in the device Press key F7 MU2 Rev 2 02 2013 10 0 CALIBRATION 4
47. CONFIGURATION PROGRAM 0 INTERNAL DATABASE 1 CLOCK CALENDAR UREMENT SYSTEM TRANSDUCER TYPES 2 2 2 RANGES AND MEASURES 2 3 MICROCONTROLLER 2 4 DATA DISPLAYING 2 5 ELECTRONIC WEATHER STATION 2 6 GENERAL DATA 2 7 APPLICABLE STANDARDS 2 8 SIMBOLOGY 2 2 22 NENNNNNNNNNNI gt 511 800 MU2 Rev 2 02 0 0 FUNCTIONING PRINCIPLES TURBINE TURBINE TURN DETECTOR FLEISCH NEUMOTACHOMETER LILLY NEUMOTACHOMETER DIFFERENCIAL MANOMETER FILTERS AND AMPLIFIERS ANALOG DIGITAL CONVERTER MICROPROCESSOR PHYSICAL DESCRIPTION PROGRAM MEMORY CPU CONTROLLERS QUALITATIVE DESCRIPTION WW LU 3 3 3 3 3 E CO co co 00 4 SPIROMETRY TECHNIQUE 4 1 PROCEDURE 4 2 CALIBRATIONS 4 3 REFERENCE VALUES FOR FORCED SPIROMETRY SEPAR 4 4 REFERENCE VALUES FOR FORCED SPIROMETRY ERS 93 4 5 OTHER REFERENCE VALUES 5 PRESERVATION PREVENTIVE AND CORRECTIVE MAINTENANCE 5 1 PRESERVATION 5 1 1 CLEANING OF THE PNEUMOTACHOMETER OR TURBINE TRANSDUCER 5 1 2 INTERNAL PRINTER 5 1 3 SPIROMETER PREVENTIVE MAINTENANCE CORRECTIVE MAINTENANCE 6 MODIFICATIONS ANNEX1 ELECTROMAGNETIC COMPATIBILITY ANNEX2 COMPLIANCE WITH THE DATA PROTECTION LOPD On gt 5 MU2 Rev 2 0 5 2013 10 Revised Date 2013 10 Antoni Pic Technical Manager PRODUCT CONFORMS WITH Aproved Da
48. DATOSPIR 110 120 SPIROMETER 511 800 MU2 Rev 2 02 2013 10 511 800 MU2 Rev 2 02 2013 10 DATOSPIR 110 120 SPIROMETER USER S MANUAL E 2 02 DECLARATION OF CONFORMITY SAFETY 1 INSTRUCTIONS FOR USE AND INSTALLATION INTRODUCTION PREVIEW OBSERVATIONS MODELS OF SPIROMETER DATOSPIR 110 120 1 4 DISTRIBUTION OF CONTROLS INDICATORS AND CONNEC TORS FILE eom GENERAL PANNEL RIGHT AND LEFT SIDE BACK PANNEL BASE OF THE DEVICE STANDARD ACCESSORIES OPTIONAL ACCESSORIES ALLATION AND SET UP INSTALLATION SET UP OBSERVATIONS ABOUT THE HANDLING OF THE DEVICE LOADING THE PAPER IN THE PRINTER OF FUNCTIONS OF THE SPIROMETER DATABASE PROGRAM CONFIGURATION PROGRAM CALIBRATION PROGRAM MAINTENANCE PROGRAM SPIROMETRY PROGRAM PULSE OXIMETRY PROGRAM MAXIMAL RESPIRATORY PRESSURES PROGRAM COMMUNICATIONS SYSTEM CE CONFIGURATION PATTERN CONFIGURATION COMMON CONFIGURATION SPIROMETRY CONFIGURATION OTHERS OPTIONS PULSE OXIMETRY CONFIGURATION MAXIMAL RESPIRATORY PRESSURES CONFIGURATION CEDURE FOR FORCED VITAL CAPACITY TEST FVC INPUT OF PATIENT AND ATMOSPHERIC PARAMETERS INPUT OF FORCED VITAL CAPACITY TESTS FVC DISPLAY OF THE RESULTS TYPE OF DIAGNOSIS PRINTING AND OR MEMORISATION OF THE FVC TESTS OTHER SPIROMETRIC TESTS TO THE SAME PATIENT CHANGE OF PATIENT P P P P P Pp Q n 1 5 s RPE Fd a a RPP 2 n n n in Z 5 N m P o P 1 6 1 7 V 1 8
49. E MAINTENANCE The preventive maintenance consists of all those technical actions directed to keep the device in a good condition of use Four types of preventive maintenance are established 1 The equipment every time it starts up checks some parts of itself 2 Asecond type which can be carried out by the same user consists of a periodi cal supervision of the aspect of the different interconnections and other external elements of the system In this supervision you will verify that all the interconnec tions are perfectly connected and all the cables and or connectors as well as other elements do not present breakage or external damages In case of detecting some anomaly which the user cannot resolve by him inform the technical service so that they proceed to check or repair it 3 The user can access to the Maintenance Program to adjust and or verify some parts of the device as it is detailed in paragraph 1 15 4 Afourth type consists on a general technical verification of the safety systems adjustments functions etc which configure the system THIS TECHNICAL VERIFICATION WILL BE DONE WITHAN ANNUAL PERIODIC ITY and according to the Manufacturer s Verification and Adjustment Procedure of the DATOSPIR 110 120 Qualified technical personnel of the maintenance depart ment of the center technical service of your distributor or the manufacturer must perform this type of operations In any case SIBEL S A as the manufactu
50. EX SPO USER MANUAL Doc 511 890 MU2 02269 TRANSDUCTOR DESECHABLE Compuesto por DISPOSABLE TRANSDUCER Including 7778 1 MANGO TRANSDUCTOR DESECHABLE DISPOSABLE TRANSDUCER HANDLE 03169 50 TRANSDUCTOR DESECHABLE DISPOSABLE TRANSDUCER 01150 1 ADAPTADOR CALIBRACI N CALIBRATION ADAPTER 07182 1 CABLE IMPRESORA PARALELO CENTRONICS CENTRONICS PARALLEL PRINTER CABLE 02483 2 1 MODULO ESTACI N METEOROLOGICA 2 METEREOLOGICAL STATION MODULE 01497 1 BATERIA RECARGABLE RECHARGEABLE BATTERY Ni Cd 12V 1 5A 01502 1 BOLSA DE TRANSPORTE CARRYING BAG 01207 1 ALIMENTADOR EXTERNO EXTERNAL POWER SUPPLY 100 130V 07535 D 02738 1 OPCI N SOFTWARE PRUEBAS BRONCOCONSTRICCI N BRONCHOCONSTRICTION TESTS SOFTWARE OPTION 02205 1 OPCI N SOFTWARE INCENTIVO GR FICO NINOS INCENTIVE GRAPHIC FOR CHILDREN SOFTWARE OPTION 01480 1 OPCI N SOFTWARE BASE DE DATOS 150 PRUEBAS INTERNAL DATABASE 4 150 TESTS SOFTWARE OPTION 01481 1 OPCI N SOFTWARE BASE DE DATOS 500 PRUEBAS INTERNAL DATABASE 4 500 TESTS SOFTWARE OPTION 01805 1 OPCI N SOFTWARE CONEXI N A IMPRESORA EXTERNA CONNECTION TO EXTERNAL PRINTER SOFTWARE OPTION 03031 1 OPCI N PULSIOXIMETRIA SOFTWARE W 20 PULSEOXIMETRY W 20 SOFTWARE OPTION 03030 1 OPCI N PIM PEM SOFTWARE W 20 MEP MIP W 20 SOFTWARE OPTION 03028 1 OPCI N BRONCOCONSTRICCI N SOFTWARE W 20 BRONCHOCONSTRICTION W 20 SOFTWARE OPTION STANDARD OPCIONAL OPTIONAL NO DISPONIBLE NOT AVAILABLE 511 800 MU2 Rev 2 02 20
51. N SOFTWARE INCENTIVO GRAFICO NINOS INCENTIVE GRAPHIC FOR CHILDREN SOFTWARE OPTION 01480 1 OPCION SOFTWARE BASE DE DATOS 150 PRUEBAS INTERNAL DATABASE 150 TESTS SOFTWARE OPTION 01481 1 OPCI N SOFTWARE BASE DE DATOS 500 PRUEBAS INTERNAL DATABASE 500 TESTS SOFTWARE OPTION 01805 1 OPCI N SOFTWARE CONEXI N A IMPRESORA EXTERNA CONNECTION TO EXTERNAL PRINTER SOFTWARE OPTION 03031 i OPCION PULSIOXIMETRIA SOFTWARE W 20 PULSEOXIMETRY W 20 SOFTWARE OPTION 03030 1 OPCION PIM PEM SOFTWARE W 20 MEP MIP W 20 SOFTWARE OPTION 03028 1 OPCION BRONCOCONSTRICCION SOFTWARE W 20 BRONCHOCONSTRICTION W 20 SOFTWARE OPTION _ STANDARD OPCIONAL OPTIONAL NO DISPONIBLE NOT AVAILABLE 1 Alimentador externo para opci n SpO2 sin interruptor Power supply for SpO2 option without switch 2 El m dulo estaci n meteorol gica no es compatible con la opci n SpO2 The wether station module is not compatible with the SPO2 option NOTA EN CASO DE INCLUIRSE DE SERIE DOS MODULOS QUE IMPLIQUEN LA INCLUSION DEL MISMO ELEMENTO POR EJEMPLO EL ELEMENTO 140 550 010 EN LOS MODULOS DE FLEISCH Y TURBINA SOLAMENTE SE INCLUIRA UNO LOS ARTICULOS Y CANTIDADES RELACIONADAS ANTERIORMENTE HAN SIDO CUIDADOSAMENTE COMPROBADAS EN CASO DE FALTAS O DESPERFECTOS PROCEDAN A COMUNICARNOSLO LO MAS PRONTO POSIBLE SI DETECTA ALGUN DETERIORO EN EL EMBALAJE CONTACTE INMEDIATAMENTE CON LA AGENCIA DE TRANSPORTE Y CO
52. N SU DISTRIBUIDOR ANTES DE PROCEDER A INSTALARLO NO SE DEBE DESPRENDER DE LOS EMBALAJES BOLSAS ETC HASTA QUE VERIFIQUE TOTALMENTE EL CORRECTO FUNCIONAMIENTO DEL EQUIPO SIRVANSE DEVOLVERNOS UNA COPIA DEL ALBARAN SELLADA Y FIRMADA 511 800 MU2 Rev 2 02 2013 10 RELACI N DE CONTENIDO PACKING LIST P gina 1 de 3 DATOSPIR 120 511 808 010 REV 2 01 2012 05 MODELOS MODELS C DIGO CANT DESCRIPCI N A B C D CODE QTY DESCRIPTION 1 DATOSPIR 120 MODELO MODEL SN 118 01555 100 BOQUILLA CART N DESECHABLE DISPOSABLE MOUTHPIECE 02692 1 PINZA NASAL NOSE CLIP 1 DATOSPIR 110 120 MANUAL DE USO Doc 511 800 MU1 DATOSPIR 110 120 USER MANUAL Doc 511 800 MU2 01208 1 ALIMENTADOR EXTERNO EXTERNAL POWER SUPPLY 220V 07536 1 02635 2 PAPEL TERMOSENSIBLE THERMOSENSITIVE PAPER 50x57 25m 02634 2 PAPEL TERMOSENSIBLE THERMOSENSITIVE PAPER 50x110 25m 03165 1 TRANSDUCTOR TIPO TURBINA Compuesto por TURBINE TRANSDUCER Including 07425 1 e MANGO ALOJAMIENTO TURBINA TURBINE HANDLE HOUSING 01305 1 TURBINA TURBINE 01809 T CABLE TELEFONICO TELEPHONIC CABLE 3 5m 01172 1 ADAPTADOR TELEFONICO A 5 TELEPHONIC ADAPTER A DB15 03171 1 NEUMOTAC METRO TIPO FLEISCH Compuesto por FLEISCH NEUMOTACHOMETER Including 02339 1 MANGO NEUMOTACOMETRO FLEISCH 02534 1 FLEISCH NEUMOTACHOMETER HANDLE 01823 NUCLEO NEUMOTACOMETRO NEUMOTACHOMETER CORE 01563 2 e CONO LINEALIZADOR LINEARIZER CONE 2
53. P MODULE Including 82268 SONDA OBTURADORA PIM PEM MEP MIP SHUTTER PROBE 01566 BOQUILLA MULTIUSO ADULTOS MULTIUSE ADULTS MOUTHPIECE 1 MANUAL DE USO ANEXO PIM PEM Doc 511 8D0 MU1 ANNEX MEP MIP USER MANUAL Doc 511 8D0 MU2 02446 1 SONDA SNIF PARA ADULTOS SNIF PROBE FOR ADULTS Requiere PLACA PIM PEM MIP MEP BOARD required 06998 1 MODULO SNIF Compuesto por SNIF MODULE Including 07266 1 SONDA SNIF PARA ADULTOS SNIF PROBE FOR ADULTS 04108 1 PLACA PIM PEM MIP MEP BOARD 1 INTERCONEXI N PIM PEM MIP MEP CONNECTION 02487 1 M DULO PULSIOXIMETRIA Compuesto por PULSE OXIMETRY MODULE Including 01846 1 SENSOR PULSIOXIMETRIA SPO PULSE OXIMETRY SPO SENSOR 1 MANUAL DE USO ANEXO SPO Doc 511 890 MU1 ANNEX SPO USER MANUAL Doc 511 890 MU2 511 800 MU2 Rev 2 02 2013 10 RELACI N DE CONTENIDO PACKING LIST P gina 2 de 3 DATOSPIR 110 511 808 020 REV 2 01 2012 05 C DIGO CANT DESCRIPCI N A C CODE QTY DESCRIPTION 07182 1 CABLE IMPRESORA PARALELO CENTRONICS CENTRONICS PARALLEL PRINTER CABLE 02483 2 1 MODULO ESTACI N METEOROL GICA 2 METEOROLOGICAL STATION MODULE 01497 1 BATERIA RECARGABLE RECHARGEABLE BATTERY Ni Cd 12V 1 5A 01502 1 BOLSA DE TRANSPORTE CARRYING BAG 01207 1 ALIMENTADOR EXTERNO EXTERNAL POWER SUPPLY 100 130V 07535 4 02738 1 OPCION SOFTWARE PRUEBAS BRONCOCONSTRICCION BRONCHOCONSTRICTION TESTS SOFTWARE OPTION 02205 1 OPCIO
54. PIRATION is not shown on the screen please verify that there is some inspiratory parameter selected in the Spirometry Configuration menu see section 1 7 3 511 800 MU2 Rev 2 02 0 4 Press key F5 and keep the neumotachometer or transducer quiet until an intermittent arrow appears on the screen Through key F6 the graphic presentation mode changes 511 800 MU2 Rev 2 02 2013 10 When the device has detected the end of the expiratory manoeuvre accord ing to ATS ERS criteria volume accumulated during the last second lower than 0 025 litres warns with an acoustic signal to start the inspiratory cy cle or finish the manoeuvre 5 The previous screen presents or gives access to the following information Date patient code and type of test Warnings of Nonconformity with the 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 Time in seconds of the expiratory plus the inspiratory manoeuvre Graphic in mode Flow Volume or Volume Time FVC and FEV1 value
55. Y CONFIGURATION 16 25 1999 12 06 511 800 MU2 Rev 2 02 2013 10 1 7 4 OTHERS OPTIONS OTHERS 23 80 2607 10 27 F2 The applicance of the ATS ERS criteria of the Start End and or Time of the manoeuvre as well as the date of the last calibration can be printed or not in the report EX Incorrect Start of the manoeuvre ET Incorrect End of the manoeuvre TT Incorrect Time of the manoeuvre Time Audit Show the time when the manoeuvre was performed It s shown in the first line of the parameters list both in the screen and in the report F4 The user can adjust the level of the incentive as he wants according to First manoeuvre of the FVC value according to the Reference Rest of manoeuvres of the FVC value according to the Best 1 7 5 PULSE OXIMETRY CONFIGURATION According to Annex PULSE OXIMETRY if this option is included 1 7 6 MAXIMAL RESPIRATORY PRESSURES CONFIGURATION According to Annex MAXIMAL RESPIRATORY PRESSURES if this option is included 511 800 MU2 Rev 2 02 0 1 8 PROCEDURE FOR FORCED VITAL CAPACITY TEST FVC The procedures to be used in order to perform the Forced Vital Capacity tests FVC slow Vital Capacity VC and Maximal Voluntary Ventilation MVV are very similar Therefore a detailed description will be done only in this point From the Main Menu screen press key F5 18 25 1999 12 87 F2 Input of a new patient if it appears
56. and hit is lower than 0 6 seconds The cursor goes to the next character when pressing a different key or after 0 6 seconds from the last hit This method is similar to the one used in the celular tel ephones It is only possible to enter characters in capital letters The available characters are Key 1 2 1 2 3 4 hits 1 2 C 511 800 MU2 Rev 2 02 0 O ouzarm Nz dozr m The third hit on the key 1 corresponds to the blank space 88 ACur 48 His 93 ted 9 1 29 Ft F ree EE H MANUEL m Suen PEREZ GUTIERREZ zn voa His For the disposable the display appears like this Si se pulsa F8 se acceder a la pantalla que permite la intrudcci n del C digo Transductor siempre que el Transductor sea un Desechable El n mero a intro ducir en esa pantalla debe coincidir por el indicado en la etiqueta de cada bolsa zu F 4 Hex a 511 800 MU2 Rev 2 02 2013 10 If the lot is not already introduced the next screen appears to be able to write down the K s Oo tii oce meaning of each field is as follows Code Field of 10 numeric or alphanumeric characters according to the configured option Age Number corresponding to the years between 4 and 100 both inclusive Weight Idem for the weight i
57. ation of PD20 FEV1 by mathematics adjustment or linear interpolation Numeric and graphic dose response data summary on screen Link with bronchodilatation test 2 1 6 PULSE OXIMETRY SpO2 The technical specifications are detailed in Annex PULSE OXIMETRY 2 1 7 MAXIMAL RESPIRATORY PRESSURES The technical specifications are detailed in Annex MAXIMAL RESPIRATORY PRESSURES 2 1 8 CALIBRATION Calibration Program for dynamic tests with syringe of 1 to 6 litres of volume Register of the last calibrations Indicaci n if wanted of calibration warnings 511 800 MU2 Rev 2 02 2013 10 2 1 9 CONFIGURATION PROGRAM PATTERN configuration selectable by the user Language printer report header etc configurable by the user Spirometry configuration Reference parameters Observed parameters Graphic selection Diagnosis Selection Report configuration Etc Pulse oximetry configuration Maximal Respiratory Pressure 2 1 10 INTERNAL DATABASE Storage of spirometric test pulse oximetry and maximal respiratory pressures Two types of database according to their storage capacity 2 1 11 CLOCK CALENDAR Hour minute second Day Month Year Stopwatch 2 22 MEASUREMENT SYSTEM 2 2 1 TRANSDUCER TYPES Fleisch neumotachometer linearized by software It can be disassembled for cleaning and sterilisation It includes a semiconductor differential manometer with internal temperature compensation Fleisch
58. e previous step but with the third dose of drug The process can be repeated until itis convenient The system allows applying a maximum of 9 doses CONSTRIC BC9 6 When the lung function parameters show a significant response after a new confirmation or according to the criteria of the operator who makes the test the bronchial provocation test can be finished The system analyses and shows the value of PD20 graphical and numerically 7 CONST DILAT Finally once the test is finished the bronchodilator drug has to be applied to revert the resultant bronchoconstriction Up two steps can be made in this modality 1 12 2 INPUT OF TEST DATA Press key F4 in the next screen 16 25 1999 12 607 511 800 MU2 Rev 2 02 0 There will appear The procedure to follow for the input of the patient and environmental parameters is the same as the one described in point 1 8 1 OF PATIENT AND ENVI RONMENTAL PARAMETERS Cote LETT Aty 33 92 amp mlen T Et F Ee MANUEL _ m BERETGUTERREZ Til Hv Once the previous data are filled in press F7 Short Mode Use Disolution Time between Const tmin Time between Dilat tmin Initial Dose gt EC drug METHACHOLINE BD drug SALBUTAMOL 18 26 1999 09 31 These data can be set up in the Configuration Program Select the method
59. ection No 15 Housing for the Electronic Weather Station 6 z 511 800 MU2 Rev 2 02 2013 10 1 4 4 BASE OF THE DEVICE No 16 Housing of the lithium type battery CR2032 No 17 Housing of the Ni Cd battery of 12 V 1 5 Ah Y e i 1 4 5 STANDARD ACCESSORIES No 18 Disposable mouthpiece IMPORTANT No 19 i TO TAKE OUT THE LITHIUM BATTERY THE EQUIPMENT WORKING IF YOU TAKE IT OUT WITH THE EQUI TURNED OFF THE CALIBRA d upply TION FACTORS WILL BE LOST Thermal paper of 57 or 111 mm No 23 Neumotachometer type Fleisch with holder No 24 Transducer with turbine No 25 Spirometry Software W 20 DEMO and Connection No 26 Handle and Disposable Transducer 511 800 MU2 Rev 2 02 0 1 4 6 OPTIONAL ACCESSORIES depending on model Spirometry Software W 20 license Accessories option MIP MEP Accessories option pulse oximetry SpO2 Transducer type disposable with holder Transport bag Calibration syringe 511 800 MU2 Rev 2 02 2013 10 1 5 INSTALLATION AND SET UP 1 5 1 INSTALLATION The spirometer DATOSPIR 110 120 is CLASS Ila according to the criteria of Euro pean Directive for Medical Devices 93 42 EEC According to the type of protec tion against electric discharges established in the norm EN60601 1 is classified as CLASS I type B The spiromet
60. enoez SEPAR Ethnic FC 100 Motive Procedence Techni Transducer Fleisch REPORT MAMOEDURE 1 1 Datei 30 16 1999 PARAMETER ORS REF WU tl wmin5 158 82 166 76 94 Er hin 44 12 bt d d bebe P d d dk Kl min 511 800 MU2 Rev N 2013 10 1 11 PROCEDURE FOR THE POSTBRONCHODILATION TEST The aim of this functioning mode is to have the spirometric results before PRE and after POST the application of a bronchodilator drug in the same report This test can be performed in modes FVC VC and MVV provided that a test in PREbronchodilation or basal mode has been performed and stored previously See point 1 8 5 PRINTING AND OR MEMORISATION OF FVC TESTS The sequence to perform the test is the following 1 Perform test FVC VC or MVV before applying the dilation drug as de scribed in the previous chapters 27 Memorise the PRE test to compare it in POST mode 3 Apply the drug to the patient in the corresponding dose according to the specialist criteria Wait for the normalised time 4 Enter the POSTBRONCHODILATION mode from the SPIROMETRY screen by pressing F3 18 25 1999 12 87 A similar display to this will appear 511 800 MU2 Rev 2 02 2013 10 DILATATION 16 25 1999 13 20 This screen shows the memorised tests in PRE mode The size of this memory is limited to 6 manoeuvres FVC of 10 seconds each or 2 manoeuvres VC of 30 seconds each or 4 mano
61. er DATOSPIR 110 120 works in standard mode with an external power supply which is connected to the mains power of 200 to 240 V 50 60 Hz with earth inlet 100 to 130 V 50 60 Hz can also be ordered or optionally with a rechargeable internal battery with exception of the models with Fleisch neumotachometer Do not charge other type of batteries they could explode If you are not going to use the device for a while remove the battery to avoid they could spill its substances The maximal power required including the heater of Fleisch neumotachometer is under 25 VA Internal battery The consumption of electrical power that the device needs specially by the backlight of the large LCD limits the battery duration Therefore it is recom mended to use this functioning mode only in emergency cases or in places that do not have mains power supply The battery is Ni Cd 12V 1 5Ah and offers an autonomy of 1 5 hours approxi mately The charging time is about 16 hours Remind that if the light of the power supply is on the battery is charging even though the device is turned off To save power the device has incorporated two auto shutdown systems The first one makes the screen backlight turn off when two minutes pass without any key press The device sleeps until one key is pressed recovering the in formation previously displayed The second system performs an autoshutdown after fifteen minutes without working In this case the informatio
62. euvres MVV of 15 seconds each or a combination of these with a total time of 60 seconds 5 Select a PREbroncho test to be compared through keys F5 and F6 to place and F7 to validate Next the screen shows the graphic PRE with which the POST is being compared FUC REF 4 24 3 28 FRE 4 22 3 58 6 Then proceed according to the described 1 8 2 and next points In this case the curve in POSTbroncho mode is compared to the stored curve in PREbroncho mode except in VC and MVV modes The screen of data presents the observed values in PRE and POST 511 800 MU2 Rev 2 02 2013 10 modes as well as the method of comparison between both ac cording to the option selected in the configuration See chapter 1 7 3 SPIROMETRY CONFIGURATION POND between PRE and POST Between REF and POST Between PRE and POST Difference between PRE and POST The most used method of comparison is the Weighted which corre sponds to POND 100x2 POST PRE POST PRE See J E Cotes Lung Function Assessment and Application in Medicine Blackwell Sci 4th Edition 1 979 52 53 The record of parameters and graphics is shown next DR JOHN SMITH SAINT PETER HOSPITAL PHEHMOLOG DATOSPIR 128 SIBELMED Code 1234567890 Date 30 10 1999 Name CHARLES FORESTER Sex Male Rge u 43 Hoht tom 176 98 2 25 Humid i 75 768 Smk I 28 References SEP R Et
63. f DATOSPIR 110 120 is its Communications System It enables to transfer data to other systems Transfer Data of the Device Check up Update the Software from a PC Transfer the Tests of patients to a PC Export Tests of patients to other Management Systems All the communications system is performed through the RS232C serial channel in the device and through the corresponding software standard or optional 1 16 1 TRANSFER OF DEVICE CHECK DATA AND OF THE DATABASE The DATOSPIR 110 120 has a program that auto checks the functioning of certain parts of the device displaying the information on screen and storing it in an internal file The available information is Hardware Check Software Check up Device configuration Record of Calibrations Test of FVC with pattern curve 511 800 MU2 Rev 2 02 2013 10 If some problem is detected and the user cannot solve it the first alternative is to send the auto check information to the After Sales Service of SIBEL S A or your distributor who will analyse and evaluate the cause of the problem or will propose the adequate solution Spirometry Software Sibelmed W20 in demo mode or enabled is required to transfer this information The program in demo mode is included as standard with the equipment The process to follow is this 1 Start the DATOSPIR 110 120 From the Main Menu screen press F4 key MAINTENANACE and enter the option F5 Auto check Execute all the sub options availab
64. for saving and processing the details of his patients according to the Law 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 Other important issues 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 110 120 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 0 eo MU2 Rev 2 02 2013 10 511 800 MU2 Rev 2 02 2013 10
65. garding the electromagnetic compatibility EMC and it should be installed and setup according to the EMC information attached See Appendix 1 ELECTROMAGNETIC COMPATIBILITY The use of transducers accessories and cables different to the ones specified here except the transducers and cables sold by the manufacturer as spare parts could adversely affect patient safety cause a malfunction of the equipment and or produce an increase of the emissions or a decrease in the device immunity REMOVAL OF WASTE FROM ELECTRICAL AND ELECTRONIC APPLIANCES BY DOMESTIC USERS IN THE EUROPEAN UNION his symbol on the product indicates that you cannot 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 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 511 800 MU2 Rev 2 02 2013 10 511 800 MU2 Rev 2 02 2013 10 1 INSTRUCTIONS FOR USE AND INSTALLATION 1 1 INTRODUCTION The spirometer DATOSPIR 110 120
66. he previous screen and follow the instruc tions indicated in the point 1 8 1 As mentioned above when entering this option and a new patient code the available information of the previous patient is deleted except the informa tion stored in the Internal DataBase or the information stored to perform a Postbronchodilatation spirometry 1 9 PROCEDURE FOR SLOW VITAL CAPACITY TEST VC The procedure to perform the slow Vital Capacity test VC is similar to the one described in point 1 8 PROCEDURE FOR FORCED VITAL CAPACITY TEST FVC with the following variations 1 Enter the VC test and perform a manoeuvre 511 800 MU2 Rev 2 02 0 uc Tu ML 3 76 1 23 LET 3 76 1 23 ED 2 The presentation of the axis is always made in VOLUME TIME mode the incentive is not available The maximum time to perform the manoeuvre is 45 seconds They are put in order beginning with the manoeuvre of higher VC 4 To measure correctly the parameters ERV and TV each manoeuvre must at least have four respiratory cycles at basal level 5 The record of parameters and graphics is displayed next according con figuration It is not allowed to superpose the manoeuvres in VC mode as they will not give any complementary information 511 800 MU2 Rev 2 02 2013 10 DR JOHM SMITH SAINT PETER HOSPITAL PNEUMOLOGY DATOSPIR 1208 SIBELMED 1224567898 CHARLES FORESTER Sex Male Heht om 6
67. heater time is 5 minutes approx from the moment of entering the Spirometry Program The heater avoids the condensation inside and performs the measuring in BTPS conditions Body Temperature and Pressure and Saturated with water vapour this is in the conditions of the air in the lungs The transducers type turbine or disposable are not heated but the spirometric data are presented in BTPS conditions 274 Verify that the neumotachometer or transducer is assembled as detailed in the following pictures 511 800 MU2 Rev 2 02 0 c 3 Train the patient in the test performance because his collaboration is es sential for the correct realization Put him the nose clip Explain to the patient to hold the pneumotachometer quietly to start blowing The pneumotachometer should be hold in the same position until the end of menoeuvre Check point 4 SPIROMETRY TECHNIQUE The patient can make the spirometric manoeuvre in two different methods The first method consists of starting the manoeuvre over the neumota chometer or transducer with the FORCED EXPIRATION followed by the FORCED INSPIRATION if necessary The second method consists of the patient breathing normally through the neumotachometer or transducer When the operator indicates fill the lungs completely and then start the FORCED EXPIRATION followed by the FORCED INSPIRATION if necessary Note if an FVC loop has to be recorded and the FORCED INS
68. hnic Fix 100 Motive Procedence Techn Transducer Fleisch 511 800 MU2 Rev 2 02 2013 10 FUC REPORT MANOELIURE N 3 4 PARAMETER iw Rest FUC Best FEVi a ao 922858 FET LOGY g FEVI FEF i MI 1 2 FIUC 1 mue UEM JACI We cn Cn 3 ED VE OO S ot EIE 511 800 MU2 Rev 2 02 2013 10 1 12 PROCEDURE FOR THE BRONCHOCONSTRICTION OR BRONCHIAL PROVOCATION TEST 1 12 1 DESCRIPTION OF THE TEST For the performance of the bronchoconstriction or bronchial provocation test is recommended to those people who are not familiarised with this type of test to check some bibliography about it See The European Respiratory Journal Volume 6 Supplement 16 March 1993 o Normativa para los Tests de Provocaci n Bron quial Inespec fica by the Sociedad Espa ola de Neumologia y Cirugia Tor cica among others The bronchoconstriction tests consist of performing a forced spirometric test after the application of different pharmacological stimulus to the patient and then evaluate the changes produced in the spirometric parameters specially the drop of FEV1 It must be taken into account that each test has several forced spirometric manoeu vres and it selects the best one to include in the summary report according to the
69. is a compact device based on different types oftransducers Fleisch turbine and or disposable a wide liquid crystal backlighted screen and an internal or external printer It can incorporate a module for measuring the Maximal Inspiratory and Expiratory Pressures MIP MEP and another module for Pulse oximetry measurements SpO2 Furthermore it has the possibility through an optional software to connect with a computer PC in real or deferred time in order to perform the spirometric tests with the PC support to store the performed tests or to transfer information by other means All the system is controlled by a microprocessor for the acquisition calculation and display of alphanumeric and graphic data The DATOSPIR 110 120 series has four models depending on the options incor porated as detailed below The spirometer DATOSPIR 110 120 has been developed by the R D Department of SIBEL S A in collaboration with Laboratorio de Funci n Pulmonar del Hos pital de la Santa Creu y Sant Pau de Barcelona The device meets the criteria of standardisation of International Institutions ATS ERS American Thoracic Society European Respiratory Society etc as well as Local Institutions SEPAR Sociedad Espanola de Neumolog a y Cirug a Tor cica etc The spirometer DATOSPIR 110 120 has been designed and manufactured ac cording to the Quality Manual of SIBEL S A which meets the quality regulations EN 46001 and ISO 9001 as well as the Medical
70. le following the indications of the screen 2 Interconnect the device with the PC CONNECTION LINK and the PC through the serial port 3 Run the previously installed W 20 Spirometry Software making sure that the DATOSPIR 110 120 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 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 If you do not have e mail you can print the data and transfer them through the FAX 1 16 2 SOFTWARE UPDATING 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 In the case of the latter SIBEL S A will provide a new update key In case of the former consult the key in the equipment before starting the update process 1 With the DATOSPIR 110 120 working from the main menu press F4 Maintenance and then press F8 Other Options Register the updating password required in the PC 511 800 MU2 Rev 2 02 0 2 Stop the DATOSPIR 110 120 and start it while pressing key
71. lifetime of 1700 disinfections or 7 years Turbine transducer volumetric bi directional axial turbine with optoelectronic turn ing sensor that can be disassemble for cleaning and sterilisation The pivot turns over sapphire shaft to obtain high reproducibility and duration Turbine lifetime of 600 disinfections or 3 years Disposable grid transducer Lilly linearized by software and calibrated for disposable use It includes a semiconductor differential manometer with internal temperature compensation Mesh disposable transducers Lilly of SIBELMED are the most reliable on the market as they are individually pre calibrated at the factory where a calibration factor is associated with them This calibration factor must be introduced into the 511 800 MU2 Rev 2 02 0 spirometer Only one factor for pack of transducers If in the future you acquire a new pack of disposable transducers remember to update the calibration factor in the spirometer 2 2 2 RANGES AND MEASURES Fleisch Turbine Disposable Measuring scale Flow 1 5 0 to 16 0 to 16 0 to 6 Volume I 0 to 10 0 to 10 Oto 10 Dynamic Resistance to flow kPa l s 0 03 0 06 0 06 Accuracy Volume whichever greater 3 or 50 ml 396 or 50 ml 3 or 50 ml Flow whichever greater 5 200 5 or 200 ml 5 or 200 ml Timer best of 0 5 0 5 0 5 Volume Resolution ml lt 1 lt 6 lt 3 Sampling frequency Hz 100 25 100 2 3 MICROCONTROLLER Sy
72. mHg from 3000 to 400 meters aprox Storage Temperature 5 a 70 C Exception storage temperature for termosensitive paper for internal printer 5 a 40 C Power supply 220 V 10 50 60 Hz others opctional Rechargeable battery 1 5 Ah Only for models without Fleisch Power Below 25 VA Size 210 x 297 x 95 mm Weigth 1 7 Kgr aprox Without accesories Life time 7 years 511 800 MU2 Rev 2 02 2013 10 2 7 APPLICABLE STANDARDS 1 Related to the product MEDICAL DEVICE 93 42 CEE Directive RD 1591 2009 ELECTRICAL SAFETY e EN 60601 1 2006 AC 2010 Seg medical equipment Class I EMC e EN 60601 1 2 2007 AC 2010 EMC in medical equipment Not vital support See APPENDIX 1 ELECTROMAGNETIC COMPATIBILITY SPIROMETRY Standards e EN ISO 26782 2009 AC 2009 Equipment of Anaesthetic and respiratory resuscitation Spirometers for measuring forced expiratory volume during a time interval in humans e EN ISO 23747 2009 Spirometers for peak expiratory flow Recommendations e SERIES ATS ERS TASK FORCE No 1 Miller MR Crapo R Hankinson J et al General considerations for lung function testing Eur Respir J 2005 26 153 161 No 2 Miller MR Hankinson J Brusasco V et al Standardisation of spirometry Eur Respir J 2005 26 319 338 No 3 V Brusasco R Crapo and G Viegi Standardisation of the Measurement of lung volume Eur Respir J 2005 26 511 522 e Sanchis et al Regulations for spirometr
73. n of malfunction Chart Variability of the spirometry in a healthy person Variables age 6 20 years 20 70 years FVC 1 9 2 2 FEV1 2 2 2 2 FEF 25 5 6 5 4 8 MEF 50 FVC 5 3 4 7 Values corresponding to 33 healthy volunteers Values of 20 healthy adults 4 3 REFERENCE VALUES FOR FORCED SPIROMETRY SEPAR The DATOSPIR 110 120 spirometer incorporates the tables of reference of the SE PAR except if the equipment is destined to outside of the Spanish territory In this case unless otherwise stated the ECCS 93 reference values for adults between 18 and 70 years are incorporated 511 800 MU2 Rev 2 02 2013 10 FEV1 FEV1 FVC FEF 25 5 PEF MEF 50 FVC MEF 25 FVC FEV1 FEV1 FVC FEF 25 75 PEF MEF 50 FVC MEF 25 FVC FEV1 PEF FEV1 FEV0 5 MEF50 MIF50 PEF PIF FEV1 FIV1 Ecuation 6 20 years R SEE 0 02800 0 03451P 0 05728E 3 21 0 947 0 443 0 03049T 0 02220P 0 03550 3 04 0 935 0 313 0 02483T 0 02266P 0 07148E 2 91 0 945 0 378 0 02866T 0 01713P 0 02955E 2 87 0 940 0263 0 593E 0 113P 81 60 0 026T 82 60 0 038T 0 140E 4 33 0 832 0 796 0 046T 0 051E 4 30 0 789 0 651 0 075T 0 275E 9 08 0 907 1 073 0 073T 0 134E 7 57 0 879 0 831 0 0171 0 157E 0 029P 2 17 0 856 0 811 0 046T 0 067E 4 17 0 803 0 669 0 024T 0 066E 2 61 0 760 0 562 0 027T 0 032E 2 68 0 709 0 507 Ecuation 20 70 years R SEE 0 0678T 0 0147E 6 05 0
74. n Kg between 15 and 200 Height Idem for the height in cm between 50 and 230 Sex Through the key 1 for FEMALE and the key 2 for MALE Cid Cigarettes day Between 0 and 100 Smoker l Smoker Index between 0 200 cigarettes day multiplied by the number of years This index is the same as the number of cigarettes smoked per day divided by 20 and multiplied by the number of years as a smoker Cigarettes day x years as a smoker 20 Et F Ethnic factor between 80 and 120 The ethnic factor is used in those places which do not have own reference parameters and use some existing and corrected in certain percentage This factor MUST BE IN 100 IF IT IS NOT USED and it can only be modified hrough the Configuration Program Name Alphanumeric field of 20 characters it can be omitted Surname Alphanumeric field of 25 characters it can be omitted The environmental parameters are received by the DATOSPIR 110 120 automati Cally the ELECTRONIC WEATHER STATION is available which is inserted in the connector no 15 of the back pannel If this option is not available the parameters are entered manually from the environmental data available of the room where the test is performed T C Room Temperature between 10 and 40 C P mmHg Environmental pressure between 430 and 800 mmHg from 4500 to 400 metres high approx H 96 Relative humidity between 0 and 100 Once the data have been entered correctly press key F7
75. n on screen is lost To start the device follow the normal procedure The working ambient conditions are Ambient temperature from 10 C to 40 C American Thoracic Society recommends from 17 to 40 C Humidity lt 85 without condensation Atmospheric pressure from 525 to 800 mmHg de 3000 a 400 metros aprox 511 800 MU2 Rev 2 02 2013 10 Storage temperature from 5 C to 70 C Exception termosensible internal printer paper from 5 C to 40 C The main power cable includes an earth protecting wire since it is necessary for the spirometer as for any other electromedical device CLASS according to EN60601 1 to be connected to earth Remember notto place the device near the water or other liquids avoiding to splash over it Do not cover the device with objects that obstruct the air circulation around it during its functioning The sequence of operations to configure the DATOSPIR 110 120 in order to per form the spirometric tests is the following 1 Connect the power supply outlet to the power inlet no 11 2 Turn the mains switch of power supply in OFF position 0 3 Connect the power supply to the mains in accordance with voltage and frequency of the power supply Turn the mains switch of the power supply in ON position I Light on 4 Connect the Transducer to the unit through connector N 7 If all these indications are met the device is ready to be set up 511 800 MU2 Rev
76. nts deviations This is made from the pattern volume or reference for the quality control of the different spirometric tests The periodicity of the calibration is left to the user criteria SIBEL S A as manufac turer according to the different standards recommends performing the calibration daily or weekly 1 13 2 TYPES OF TRANSDUCERS The DATOSPIR 120 can work with three different types of transducers Neumotachometer type Fleisch Transducer type turbine Transducer type disposable of mesh The neumotachometer type Fleisch is the system of flow measurement of the great est acknowledgement in the pneumology field for its great reliability reproducibility and duration The transducer of turbine is a system with a good reliability being its duration limited to the use and care The transducer type disposable is an element with great reliability and reproduc ibility adequate for its use in those cases where it is necessary to avoid possible infections among patients due to undetected or non eradicated infections because of lack of cleanness in the neumotachometer or transducer used 1 13 3 PROCESS FOR CALIBRATION The steps to follow for the calibration are the following 511 800 MU2 Rev 2 02 0 1 Connect the neumotachometer or transducer to the syringe inserting a tube of 1 metre long to avoid the influence of the turbulence caused by the sudden output of air according to picture FLEISCH HOSE RECORD SYRINGE PNEUMT
77. of Pulse oximetry SpO2 Configuration of Maximal Respiratory Pressures PIM PEM 1 6 3 CALIBRATION PROGRAM Calibration with syringe Report of last calibrations 1 6 4 MAINTENANCE PROGRAM Selection of warnings Period between calibrations Period between maintenance Adjustment of LCD screen contrast Liquid Crystal Display Hardware check up Others It informs of the Program Update password and allows initialising the system Once the system is initialised the user must select the model of the internal printer installed in the device With the introduction of some keywords the following options can be configured in this menu 511 800 MU2 Rev 2 02 2013 10 100 Permits the modification of parameters alfa beta and pulse number 101 Activates the plotting of VC maneouvre with positive espiration 102 Activates the plotting of VC maneouvre with negative espiration Check up with pattern curves FVC VC MVV Adjustment of printer contrast 1 6 5 SPIROMETRY PROGRAM Forced Vital Capacity test FVC Test data Patient Code Name and surname Age height weight and sex Smoker index Ethnic Factor Environment Temperature Pressure Humidity Start of the spirometric manoeuvre Presentation of the graphic Flow Volume only in FVC Volume Time Paediatric incentive only in FVC Selection of manoeuvres Selection of the best manoeuvre Selected manoeuvre data Memory for five manoeuvres Deleting of a manoeuvre
78. of a typical commercial or hospital environment The input output line cables are shorter than 3 meters long Mains power quality should be that of a typical commercial or hospital environment 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 Ut 30 dip in Ut for 25 cycles lt 95 Ut gt 5 dip in Ut for 5 seconds lt 5 Ut gt 95 dip in Ut for 0 5 cycle 40 Ut 60 dip in Ut for 5 cycles 70 Ut 30 dip in Ut for 25 cycles lt 95 Ut gt 5 dip in Ut for 5 seconds Mains power quality should be that of a typical commercial or hospital environment If the user of the DATOSPIR 110 120 requires continued operation during power mains interruptions it is recommended that the DATOSPIR 110 120 be powered from uninterruptible power supply or a battery Power frequency 50 60 Hz magnetic field EN IEC 61000 4 8 3 A m 3 A m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial of hospital environment NOTE Ut is the a c mains voltage prior to application of the test level 511 800 MU2 Rev 2 02 2013 10 Guidance and manufacturer s declaration electromagnetic immunity DATOSPIR 110 120 is intended for use in the electromagnetic envir
79. of bi directional information between the computer and the spirometer 1 6 1 DATABASE PROGRAM Summarised display of stored tests Printing and display of a test Deleting a test Search for patient code Summarised printing of the stored tests Deleting of all the stored tests 1 6 2 CONFIGURATION PROGRAM Configuration Pattern Restores the configuration Saves the configuration Common configuration Language of work Insertion of a header in the report Selection of printer type Internal External type HPCL External type IBM Graphics Patient code and others Numeric Alphanumeric Spirometry Configuration Reference parameters Observed parameters 511 800 MU2 Rev 2 02 0 FVC VC MVV Graphic selection Store graphics in the database Print graphic Flow Volume of FVC Print graphic Volume Time of FVC Print graphic Volume Time of VC Print graphic Volume Time of MVV Print graphic Dose Response in Bronchoconstriction Selection of diagnosis Mode of comparison in POSTbronchodilatation POND between PRE and POST Between REF and POST Between PRE and POST Difference between PRE and POST Selection of intervals doses etc in Bronchoconstriction Other options Printing of Nonconformity warnings of the manoeuvres with the ATS ERS criteria Incorrect start of the manoeuvre Incorrect end of the manoeuvre Incorrect time of the manoeuvre Date of the last calibration Selection of paediatric Incentive level Configuration
80. onment specified below The costumer or the user of DATOSPIR 110 120 should assure that it is used in such an environment Immunity test EN IEC 60601 test Compliance Electromagnetic environment level level guidance Portable and mobile RF communications equipment should be used no closer to any part of DATOSPIR 110 120 including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance Conducted RF 3 Vrms 3 Vrms 25 Disposable and d P 80 MHz to 800 MHz EN IEC 61000 4 6 150KHz to 80 MHz turbine E 2Vrms Fleisch Radiated RF 3 V m 3 V m 3 5 Disposable and d P 80 MHz to 800 MHz EN IEC 61000 4 3 80 MHz to 2 5 GHz turbine E 1V m Fleisch d B 800 MHz to 2 5 GHz where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is 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 b Interference may occur in the vicinity of equipment marked with the following symbol e 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
81. or calibration are not carried out within the specified days the device warns by displaying a label in every start If 0 days are introduced it will not warn in any case Press F3 on the maintenance screen 16 26 1999 11 28 F2 Modifies the contrast of the internal printer F3 Modifies the contrast of the LCD screen 18 26 1999 11 29 511 800 MU2 Rev 2 02 2013 10 Press key F5 on the maintenance screen DEVICE CHECK UP EN SIBEL Dos de Maig 2968 Int Frn Tel 434 4368888 go Fax 34 93 3361611 pe Hmail zatisziLbelmed ez Barcelona 232 SPAIN 18 26 1999 11 31 This option enables to check up different parts of the device Internal printer 10 lines of characters in alphabetic order will be printed External printer The user should connect an external printer and select between HP PCL or IBM Graphics The SIBELMED logo the header lines and 10 character lines will be printed CPU It calculates the Flash program Checksum and the bios program checksum For more information consult with the After Sales Service It will display a warning if there are errors in external or internal RAM LCD It performs a test for the LCD the beeper and the keyboard LED following 5 steps 1 displays a BAR graphics 24 shutdowns the LCD backlight during 2 seconds 3 inverts the displaying mode in the LCD during 2 seconds 4 performs LCD contrast sweeping 5 performs 7 beeps from lower
82. rer must authorize in writing at least 511 800 MU2 Rev 2 02 2013 10 during the warranty period the corresponding technical service allowing them to make such maintenance And in any case no responsibility for damage misfunc tion etc will be admitted which might arise as a result of a defective maintenance by persons not belonging to SIBEL S A 5 3 CORRECTIVE MAINTENANCE The corrective maintenance consists of putting the device in a good condition of use which for bad operation or bad use has been put out of service and which is necessary to repair In case of detecting in the system a break down which impedes its normal use dis connect the device from the power supply and contact the corresponding technical service specifying as detailed as possible the type of anomaly detected 511 800 MU2 Rev 2 02 0 6 MODIFICATIONS 511 800 MU2 Rev 2 02 2013 10 511 800 MU2 Rev 2 02 2013 10 ANNEX1 ELECTROMAGNETIC COMPATIBILITY 511 800 MU2 Rev 2 02 2013 10 Guidance and manufacturer s declaration electromagnetic emissions DATOSPIR 110 120 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 110 120 uses RF energy only for its internal function Therefore its RF emissions are CISPR 11
83. s analysis is not enough for itself to carry out an accurate diagnosis on the patient s clinical condition therefore it must be completed with the clinical history and those tests the doctor considers necessary The tests interpretation and the derived treatments must be performed by a doctor The patient s symptoms before the execution of any spirometry test must be considered by health care personnel Health care personnel is responsible of the acceptability of a test The spirometer must not be used when results validity might be probably compromised due to external factors 511 800 MU2 Rev 2 02 2013 10 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 The device should NOT be used stacked or adjacent to other equipment The equipment must be stored and used within the temperature pressure and humidity ranges specified in this manual ELECTRICAL RISKS DO NOT remove the device or accessories cover Servicing and repair of the apparatus must only be carried out by trained personnel Contact with the voltage inside the system can cause serious injury DO NOT use damaged transducers accessories or cables DO NOT submerge the device parts in any liquid IT CAN RESULT IN ELECTRICAL DISCHARGE Consult the equipment cleaning method in Chapter 8 Section 8 1 UPKEEP PREVENTATIVE AND CORRECTIVE
84. s of Reference REF and the Observed values in each manoeuvre Mx ACT current corresponds to the last entered manoeuvre In mode F V some small squares appear which correspond to the theoreti cal values of FVC MEF2596 MEF50 and MEF75 if there are references for them The number of stored manoeuvres in this case only one M1 The icons give access to F2 Activates the paediatric incentive F5 Initialize a new manoeuvre F6 Changes the type of graphic F V or V T F Presents the data of the best manoeuvre F8 Prints the report of the best manoeuvre 6 Perform new spirometric manoeuvres The new graphic superposes to compare it with the best M1 of the stored manoeuvres The device DATOSPIR 110 120 according to the FVC FEV1 criteria of larger addition stores automatically and puts in order the five best manoeuvres in M1 to M5 being the BEST the placed in M1 and the WORST the placed in M5 It also takes into account the number of Nonconformity warnings EX FP TP being the worse the more warnings it displays The last entered manoeuvre keeps blinking and corresponds to the values ACT current If more than five manoeuvres have been entered and no manoeuvre blinks it means that the last input is worse than the five stored manoeuvres and then it will delete it If three or more manoeuvres have been performed and the labels and or FEV1 blink they warn that the reproducibility criteria is met according
85. smitter m De 150 kHz a 80 MHz De 80 MHz a 800 MHz 800 MHz to 2 5 GHz 3 5 3 5 7 w d P d P d P 3 3 3 0 01 0 12 0 12 0 23 0 1 0 37 0 74 1 1 17 2 33 10 3 69 7 38 100 11 67 11 67 23 33 For transmitters rated at maximum output power not listed above the recommended separation distance d 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 511 800 MU2 Rev 2 02 2013 10 511 800 MU2 Rev 2 02 2013 10 ANNEX2 COMPLIANCE WITH THE DATA PROTECTION ACT LOPD 511 800 MU2 Rev 2 02 2013 10 COMPLIANCE WITH THE DATA PROTECTION ACT DIRECTIVE 95 46 EC Requirements specifically affecting the use of the DATOSPIR 110 120 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 110 120 Spirometer must be handled to comply with the requirements of this act IMPORTANT WARNING According to current legislation the user of this equipment is the only party responsible
86. spiratory Volume in 1 second Relation Relation Peak Inspiratory Flow Mid Transit Time Relation Extrapolated Volume with regard to the FVC l min Maximum to indirect Voluntary Ventilation 30 x FEV1 1 Forced Expirometry Volume 6 seconds Ratio COPD Chronic obstructive pulmonary disease rate Parameter that depends 511 800 MU2 Rev 2 02 2013 10 on the number of cigarettes smoked a day the age and FEV1 Indicates the risk of COPD Age of the Lung Parameter that depends on the height and FEV1 Indicates the equivalent age of the lung Diagnosis based on Miller s Quadrant or Snider Kory 8 Lyons Percentage of Deviation regarding reference values Reference values normalised to be selected between several standards Data of Patient Identification Environmental Data of temperature pressure and relative humidity Graphics in FLOW VOLUME and VOLUME TIME mode Graphic incentive for children Warnings of manoeuvre acording to the ATS ERS criteria 5 manoeuvres of the same test can be stored Acoustic and graphic indications for start and end of manoeuvres 2 1 2 SLOW VITAL CAPACITY Parameters VC TV 1 ERV IRV 1 Ti Te s Tt Ti Tt 1 Slow Vital Capacity Tidal Volume 1 Expiratory Reserve Volume 1 Inspiratory Reserve Volume Inspiratory Capacity s Inspiratory time Expiratory time s Total time Relation Percentage of
87. stem microcontroller Hitachi s H8532 Volume accumulating time Five FVC graphs of 25 seconds maximum each one Five VC graphs of 45 seconds maximum each one Five MVV graphs of 15 seconds maximum each one FVC expiration start By retrograde extrapolation method FVC expiration end When the accumulated volume in the last second is less than 0 025 litres FVC manoeuvres selection By the maximum of FVC FEV1 criteria or as the operator wants Parameter selection FVC and FEV1 the greater ones between the stored tests Rest of pa rameters ofthe selectedmanoeuvre beingrecommended the manoeuvre of greater FVC FEV1 Keyboard All the instruction data etc that the operator transmits to the micro processor are performed by pressing a membrane keyboard Communication channel RS 232C 511 800 MU2 Rev 2 02 2013 10 2 4 DATA DISPLAYING LCD Liquid Crystal Display with 320 x 240 pixels and viewing area of 120x90 mm By means of an internal thermal printer of 58 or 112 mm wide By means of an external printer By means of a PC with the corresponding software 2 5 ELECTRONIC WEATHER STATION Temperature 0 a 50 C 1 C Pressure 375 a 785 mmHg 5 mmHg Humidity 0 a 100 596 2 6 GENERAL DATA Ambient Temperature Between 10 and 40 C American Thoracic Society recommends 17 40 C Relative humidity lt 85 without condensation Atmosferic pressure From 525 to 800 m
88. struction and every one of them has a resistance to the airflow that produces a pressure drop between extremes The reason of using so many tubes and their small diameter is the air crosses the obstruction in laminar mode In this mode the relationship between flow and pres sure for the greater flow range possible without turoulence phenomena The flows produced in the forced spirometric tests are turbulent It is interesting to obtain a correct measure that the flow will be laminar in the resistor and this is achieved straightening the tube diameter Contrary the norms say that this resistance to the airflow should be under a limit to avoid modifying the test measure The best solution is using a high number of small tubes then the flow is laminar when crosses the tubes and the total resistance is low enough to not modify the measure Actually the response of Fleisch neumotachometer is linear at low flow rates varying gradually to a quadratic realtionship in high flow rates when it is turbulent This error is about 2 for flows from 0 to 12 1 5 Nevertheless there are two flow linearizers that reduce the error These devices are two metallic grid cones Furthermore the software includes a linearization function that improves the measure To avoid the condensation and to not change the linear characteristics the neumo tachometer is heated to a temperature of 37 C 3 4 LILLY NEUMOTACHOMETER The Lilly neumotachometer consists on an
89. t available in the DATOSPIR 110 120 F2 F3 F4 F5 DOMON COHFIGIRATIOM 18 25 1999 12 86 Selection of language Insertion of a header in the report It enables to insert two lines of header with a maximum of 33 characters line Here you can write the name of the centre doctor etc and it will appear in each report Selection of printer type Code for patient and others Select among numeric and alphanumeric code It is recommended the numeric code as the second is slower to enter 1 7 3 SPIROMETRY CONFIGURATION In this option you can configurate those suboptions specific for the spirometric tests F2 F3 F4 F5 Reference Parameters Enables to select among several Selects for children and adults Prioritizes the range of age selected for adults if a different table for children is selected Extrapolates the values for the ages out of the range of the selected tables Observed Parameters Enables to select the preferred observed or measured parameters Selection of Graphics Selection of diagnosis according to 511 800 MU2 Rev 2 02 0 F6 F7 F8 Miller s quadrant Snider Kory amp Lyons algorithm Mode of comparison between PREbroncho and POSTbroncho P Weighted average between PRE and POST Percentage between REF and POST Percentage between PRE and POST Dif Difference between PRE and POST Bronchoconstriction Some aspects like mode drug time etc Others options SPIROMETRy
90. te 2013 10 Carlos Recio Sales Manager 93 42 CEE Medical Devices Directive SIBEL S A Rossell 500 08026 Barcelona Spain Tel 34 93 436 00 08 Fax 34 93 436 16 11 e mail sibel sibelmed com WEB www sibelmed com AFTER SALES SERVICE Tel 34 93 433 54 50 FAX 34 93 436 16 11 e mail sat sibelmed com 511 800 MU2 Rev 2 02 2013 10 SAFETY SPECIAL PRECAUTIONS The spirometer DATOSPIR 110 120 has been designed to have the maximum safety All the operation instructions must be read before starting the DATOSPIR 110 120 Otherwise injures to the user or the patient and damage to the device andlor accessories might occur EXPECTED USAGE The spirometer measures and calculates a long list of human respiratory function parameters The spirometer is designed to be used exclusively by health care personnel being supervised and trained by a doctor The spirometer is not designed to be used in open air conditions or under any other conditions or energy supply not foreseen in this manual PATIENT S EFFECTS IN THE SPIROMETER USAGE Spirometry tests require the patient s collaboration the patient must perform a complete forced expiration to be able to get meaningful FVC values The doctor should assess the patient s capacity to perform the spirometry tests Special precaution must be taken with children elderly people and disabled people LIMITATIONS OF USE CONTRAINDICATIONS An spirometry test result
91. tions the obtained data are inferior by 1096 approxi mately to the ones obtained with the patient sitting In patients with diaphragmatic or neuromuscular pathology the difference between both possitions can be 40 60 which makes of the observation a useful piece of information in the valuation of the repercussion of this pathology When you work with the pneumotachometer the operation can be reduced exclusively to the maximum expiration from the maximum inspiration possition The accuracy of an operation will be judged by its onset course and conclusion by observing the patient and the graph layout The onset must produce a sudden neat defec tion The course must draw a concavity curve going smoothly upwards without any rectification The conclusion should be asintotic and not perpendicular or sudden Measurement of expired volume during a force operation is influenced by the se lection of its starting point This obliges you to choose an onset criterion and to constantly maintain it The so called retrograde extrapolation is the most consistent and welcomed method by European and American laboratories and it is the choice unless other methods prove as good as this one or with similar results The volume extrapolated by this process must be inferior to 5 of FVC or 100 ml wichever is greater In order to achieve a good spirometry the technician should make sure that the patients effort is maximum that the onset is correct and that there
92. to higher frequency with a LED blinking Keyboard The test finishes showing the message Correct Test when all the keys except ON OFF are pressed The test can be aborted by pressing F1 twice ADC S It shows which transducer is connected to the device and the input voltage of this channel In a second part it displays the values of different parameters and shows if the read values are or not correct Inputs It shows if it is connected or not the external power supply the weather sta tion the MEP MIP transducer and the external printer and the internal printer header status and its paper status Select the option and follow the instructions of the screen Press key F6 on the maintenance screen 16 26 1999 11 33 It has some pre recorded curves to verify the functioning of the device FVC two curves No 1 and 2 VC one curve No 1 MVV one curve No 1 The transducer stage is not checked with these curves as for this it is necessary to enter a curve of real flow Select the option and follow the instructions on the screen similar to the procedures of FVC VC and MVV With these curves you will be able to handle the device as if they were real curves of patients 511 800 MU2 Rev 2 02 0 Press F7 key on the maintenance screen to update time and date UPDATE TIME AND DATE hh DD MM YYYY 16 26 1999 11 34 1 16 COMMUNICATIONS SYSTEM One of the great qualities o
93. to use antiseptics in so lution or more complex sterilization procedures 511 800 MU2 Rev 2 02 2013 10 CAUTION DO NOT SUBMIT THE NEUMOTACHOMETER TO TEMPERATURES EXCEE DING 70 C B TURBINE TRANSDUCER As the turbine is the piece directly exposed to the patient it is necessary to maintain itin perfect physical and hygienical conditions To this purpose proceed as follows Fig 5 4 1 The turbine can be disassembled from the device housing by pressing smoothly to take it off 2 The Turbine can be washed with soap and water Do not use solvents alcohols etc that can damage the components Since the reliability of the turbine depends on it you should take care not to damage it 3 Once cleaned it with clear water it is convenient to avoid the salt sediments by cleaning it again with distilled water 4 The final dry can be made with warm air 5 Assemble the turbine in the housing again 511 800 MU2 Rev 2 02 2013 10 umami Fig 5 5 If you suspecta microbian contamination it is necessary to use antiseptics in solution or more complex sterilizing procedures for example the immersion in a solution of Dietilentriamine or Sodium Dichloroisocianurate for 10 to 30 minutes PRECAUTION DO NOT EXPOSE THE TURBINE TO TEMPERATURES EXCEEDING 60 C OR BELOW 0 C DO NOT USE SOLVENTS ALCOHOLS OR OTHER SIMILAR SUBSTANCES DURING ITS CLEANING WHICH MAY DAMAGE IT C Disposable Transd
94. tored tests F6 Search for patient code F7 Prints the stored tests F8 Deletes all the stored tests Press F5 DATA BASE INFORMATION REG Pat Code 11 26 1999 09 B F5 and F6 Select the test F Displays the selected test F8 Deletes the selected test Use numeric keypad to select a record Select a test and press F7 F2 Changes the type of graphic F5 Presents the test data F6 Prints the test As commented above the internal database information can be transferred to a PC or to other computer systems in order to store or manage it Its description is made in point 1 16 COMMUNICATIONS SYSTEM 511 800 MU2 Rev 2 02 0 1 15 MAINTENANCE PROGRAM The device has a maintenance program that enables to adjust and or verify the functioning of certain options From the Main Menu screen press F4 18 26 1999 11 19 F2 Activates the warnings of calibration and or maintenance F3 Adjusts the screen and printer contrast F5 Device s auto check F6 Check with pre recorded pattern curves F7 Updating of Time and Date in the calendar clock F8 Several options Press F2 Last Maintenance Total Test Humber Tests since Last Maintenance Calibration Periode Maintenance Periode 18 26 1999 11 This option informs about the performed tests and enables to define the periods in days between calibrations or between preventive maintenance of the device The key F3 deletes and F7 confirms the data If the maintenance
95. ucer This transducer does not need any kind of cleaning Itis thought so it can be throwed away once the patient is done with the tests The disposable transducers are for a single use only Reutilization of the disposables transducers gives a risk of crossed infection In addition the use of disinfectant products can affect the transducer s mesh and give a loss of accuracy of the measurement REUTILIZATION OF THE TRANSDUCER GIVES A RISK OF REINFECTION OR CROSSED INFECTION THE USE OF DISINFECTANT PRODUCTS CAN AFFECT THE TRANSDUCER S MESH AND GIVE A LOSS OF ACCURACY IN THE MEASUREMENT The handle and the housing of the disposable transducer can be cleaned with a dry cloth or slightly moistened with water drying thereafter the remanent humidity trying to avoid the water to be introduced in the pressure inlets This operation must be done with the transducer cable above the transducer itself thus avoiding the introduction of strange elements in the pressure inlets 5 1 2 INTERNAL PRINTER 511 800 MU2 Rev 2 02 2013 10 Collocation of the paper For this operation it is necessary to proceed as detailed in the paragraph 1 5 4 COLOCATION OF THE PAPER 5 1 3 SPIROMETER The spirometer is smoothly wiped with a dry or slightly water moistened cloth drying thereafter the remanent humidity Take care that no liquid penetrates inside or in the connectors or connections Do not use abrasive substances or solvents 5 2 PREVENTIV
96. uded as optional At any moment if preferred a certain model can be converted into another superior model by adding the corresponding parts In this case contact with the Sales Dept of SIBEL S A or your distributor The DATOSPIR 110 has exactly the same STANDARD ACCESSORIES than the DATOSPIR 120 knowing that the DATOSPIR 110 cannot have neither the Fleisch nor the Turbine transducers 511 800 MU2 Rev 2 02 0 RELACI N DE CONTENIDO PACKING LIST P gina 1 de 3 DATOSPIR 110 511 808 020 REV 2 01 2012 05 MODELOS MODELS C DIGO CANT DESCRIPCI N CODE QTY DESCRIPTION 1 DATOSPIR 110 MODELO MODEL SN 118 02692 1 PINZA NASAL NOSE CLIP 1 DATOSPIR 110 120 MANUAL DE USO Doc 511 800 MU1 DATOSPIR 110 120 USER MANUAL Doc 511 800 MU2 01208 1 ALIMENTADOR EXTERNO EXTERNAL POWER SUPPLY 220V 07536 1 02635 2 PAPEL TERMOSENSIBLE THERMOSENSITIVE PAPER 50x57 25m 02634 2 PAPEL TERMOSENSIBLE THERMOSENSITIVE PAPER 50x110 25m 02224 1 CONEXION CON PC PC CONNECTION LINK ae O25305 1 LICENCIA SOFTWARE ESPIROMETR A W 20 SPIROMETRY LICENSE SOFTWARE W 20 SOFTWARE W 20 CD 511 8FA 02568 1 TRANSDUCTOR DESECHABLE Compuesto por DISPOSABLE TRANSDUCER Including 1 e MANGO TRANSDUCTOR DESECHABLE 03169 DISPOSABLE TRANSDUCER HANDLE 50 TRANSDUCTOR DESECHABLE DISPOSABLE TRANSDUCER 01150 1 ADAPTADOR CALIBRACI N CALIBRATION ADAPTER M DULO PIM PEM Compuesto por 02484 1 MEP MI
97. y No SEPAR recommendations 1 Arch Bronconeumol 1989 25 132 142 USABILITY AND APTITUDE FOR USE e EN 60601 1 6 20 10 General requirements for safety Part 1 6 Collateral standard Usability e EN 62366 2008 Application of engineering skills to use medical devices 511 800 MU2 Rev 2 02 2013 10 VIBRATION AND TEMPERATURE e Series EN 60721 1995 Classification of environmental conditions e Series EN 60068 1999 Environmental testing BIOCOMPATIBILITY e EN ISO 10993 1 2009 AC 2010 Biological evaluation of medical devices Part 1 SOFTWARE e EN 62304 2006 AC 2008 Software for Medical Devices DOCUMENTATION AND INFORMATION e EN 1041 2008 Information supplied by the manufacturer of medical devices e EN ISO 15223 1 2012 Symbols to be used with medical device labels labelling andi nformation to be suplplied 2 Related to the manufacturer QUALITY eEN ISO 13485 2012 AC 2012 Quality management systems Requirements for regulatory purposes e EN ISO 9001 2008 quality management Requirements e EN ISO 14971 2012 Risk management in medical equipment WASTE e RD 208 2005 Electrical and electronic equipment and waste management Transposition of WAEE 2002 96 CE Directive 3 To be satisfied by the user DATA PROTECTION e Compliance with LOPD and 95 46 CE Directive WASTE e RD 208 2005 Electrical and electronic equipment and waste management Transposition of WAEE 2002 96 CE Directive 511 800 MU2 Rev 2 02 2013 1

DATOSPIR-110/120 SPIROMETER 511-800-MU2 Rev

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