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DATOSPIR MICRO

1. Chapter 3 Models B C Operation sibelmed DATOSPIR MICRO User s Manual 150 TEST TRANSFER As with spirometric tests the pulse oximetry tests saved to the database can be transferred to a PC Remember that only parameters are saved not the curve PULSE OXIMETRY MEASUREMENTS It is possible to take pulse oximetry measurements while performing a spirometry test only in FVC and VC tests To do so the pulse oximetry finger clip must be connected when starting the spirometry While spirometry is being performed the Saturation SpO and Pulse Rate PR value will appear on the screen with the curve and will be saved in the memory The average of both values will be displayed on completion of the manoeuvre The Pulse Oximetry menu must be accessed to retrieve all the measured values from the memory This will be dealt with like a Pulse Oximetry test saved in the memory 511 00 02 REV 2 03 S be med 7 DATOSPIR MICRO User s Manual 151 3 9 CALIBRATION PROCEDURE GENERAL OBSERVATIONS The standards in force regarding spirometry recommend that all spirometers be periodically calibrated This is due to alterations which may modify the characteristics of the electronic circuits and mechanical elements over time and cause a change in the spirometer calibration factors Hence a calibration system has been incorporated based on a reference volume signal e g a syringe Furthermore t
2. Chapter 3 Models Sibelmed DATOSPIR MICRO User s Manual 162 REGISTER SEARCH REGISTER ji i Enter the register number and press If the register exists the database search screen will appear Where this is not the case the following warning message will appear REGISTER ID NOT FOUND SUMMARISED REPORT Select the option to print a report with the list of tests saved on the database The following screen will appear to indicate the printing process PRINTED REPORT 511 A00 MU2 REV 2 03 S be med 7 DATOSPIR MICRO User s Manual 163 DELETE DATABASE Select the option to delete the database The following message will appear ESC Press to accept and delete the database or press to go back to the previous screen without deleting it 511 A00 MU2 REV 2 03 2 pue g sjapow 1oe3deu Chapter 3 Models B C Operation Sibelmed DATOSPIR MICRO User s Manual 164 3 11 MAINTENANCE PROGRAMME The equipment has a maintenance programme to adjust and or check the working order of certain options From the Main Menu screen press 591326 MAINTENANCE 33 mmn Enables the calibration and or maintenance warnings Ll Adjusts the screen contrast ier TouchPannel calibration Auto checks the equipment Checks with pre saved standard curves Equipment configuration WARNINGS Select the optio
3. 1 second and release Nothing will appear on the screen 6 the Bios file DMBios tsk into the FIRMWARE directory of the application W20 7 Run the W 20 Spirometry Software access the Configuration Links option and check that the DATOSPIR MICRO is selected 8 Access the Configuration Utilities Update Bios option 9 Follow the instructions on screen and wait for the process to end 10 Once completed turn both updating switches OFF again replace the Bluetooth where applicable and close the cover FLASH UPDATE Flash can be updated for a new version of the programme in which improvements have been included or to add another option to the equipment dilation option bluetooth etc In the case of the latter SIBEL S A will provide a new update key En el primer caso antes de empezar el proceso de actualizaci n debe consultar la clave en el equipo 511 A00 MU2 REV 2 03 Sibelmed 7 DATOSPIR MICRO User s Manual 89 In case of the former consult the key in the equipment before starting the update process Switch the DATOSPIR MICRO on and select the following from the main menu MAIN MENU 5 Maintenance Access the option MAINTENANCE 4 Config Equip and consult the update key in CONFIG EQUIP 5 Update Key Stop the DATOSPIR MICRO The updating process is as follows 1 Run the W 20 Spirometry Software and access the Configuration Hardware Test option Run a communicat
4. If a Volume other than 0 has been entered the No of Pulses has not bee modified the following screen will appear 4 Press and start the calibration process emptying the syringe for two or more consecutive cycles one cycle is equal to emptying and refilling the syringe When emptying and filling the syringe plunger must move all the volume used as a reference If this is not done correctly the equipment will detect it as incorrect manoeuvres Furthermore this process should be completed in a regular and uniform manner without causing flow rates that are too high or too low Where this is not the case you will be told to repeat the manoeuvre The time for each cycle must be no less than three seconds and no more than six 5 screen shows the expiratory and inspiratory factors taken by the equipment and if they are within 2 will consider the system calibrated Where this is not the case point 4 is repeated 511 A00 MU2 REV 2 03 Sibelmed 7 DATOSPIR MICRO User s Manual 155 ERF Fat 53 INSF F 8 36 CALIBRATED Ve Yi 3 08 1 lt 24 6 Once calibrated exit the Calibration Programme and access the Spirometry programme to begin the tests Note If upon entering the calibration parameters in point 2 Calibration Volume 1 0 is allocated the system takes the calibration factors EXP F and INS F 1 00 corresponding to original factory calibration This cal
5. 0 1 2 3 4 This screen allows you to customise the different pulse oximetry parameters bottom Bot levels fro displaying SpO2 and PR trends e Reference Ref line level for both channels e On screen display time between 5s and 29m 59s ENTERING TEST DATA Start the DATOSPIR MICRO using the key wait for the main screen to appear and press the key The following screen or similar will appear depending the mode selected numeric or alphanumeric Sibelmed 7 DATOSPIR MICRO User s Manual 143 Cod 0123456789 Yrs C cm 3i DHA 56 The meaning of each field is as follows Cod Code 10 character numeric alphanumeric field depending on the customised option corresponding to the patient code Sex Between male and female Yrs Age Number corresponding to the age between 4 and 100 cm Height Height in cm between 50 and 230 kg Weight Weight in kg between 15 and 200 Enter the patient s details and press the key to go to the test screen PERFOMING PULSE OXIMETRY TESTS On accessing this screen the pulse oximeter automatically begins to take samples The Oxygen Saturation SpO and Pulse Rate PR values are displayed The top of the screen indicates the signal time trends saved in the memory to date 1 pue g Chapter 3 Models C Operation Sibelm
6. 1 2 PRELIMINARY OBSERVATIONS This User Manual is for all models and options of the DATOSPIR MICRO spirometer Therefore only specific options or functions of the model available will be applicable in each case This spirometer has been manufactured using solid state professional components under strict quality controls However accidents may occur during the transportation or storage of the equipment and it is therefore wise to initially check its condition and that of its accessories before installing them WARNING SHOULD YOU DETECT ANY DAMAGE TO THE PACKAGING CONTACT THE HAULIER AGENCY AND DISTRIBUTOR IMMEDIATELY BEFORE STARTING THE INSTALLATION PACKAGING AND BAGS ETC MUST NOT BE DISPOSED OF UNTIL THE CORRECT WORKING ORDER OF THE EQUIPMENT HAS BEEN FULLY VERIFIED 511 A00 MU2 REV 2 03 pue esr 2 1 1e3deu Chapter 1 Instructions for Use and Installation Sibelmed DATOSPIR MICRO User s Manual 1 3 DATOSPIR MICRO SPIROMETER MODELS The DATOSPIR MICRO spirometer series is made up of the following models depending on the options included DATOSPIR MICRO DATOSPIR MICRO B DATOSPIR MICRO C The enclosed tables show the basic standard features of each model and all other optional parts and functions A model can be upgraded at any time by adding the corresponding parts To do so please contact the SIBEL S A Sales Department or your distributor The main fea
7. 1o3deu Chapter 4 Communications system Sibelmed 7 DATOSPIR MICRO User s Manual 188 5 Load the files to your normal e mail programme and send to the SIBEL S A AFTER SALES SERVICE or your Distributor Who will analyse them and contact you to solve the problem presented If you do not have e mail you can print the data and send it by FAX 4 2 PATIENT TEST MANAGEMENT IN THE PC If you want ot view print manage and or save the tests in the PC you must have W 20 Spirometry Software The process to follow is 1 Save the tests required in the equipment s internal Database 2 Install the W 20 Spirometry Software as detailed in its User s Manual Load the Database data from the PC using the W 20 Software BATCH option 4 The screen shows a list of the tests transferred and you can select those to be imported to the PC Database selected in the W 20 Software Configuration option 5 From then on you can select view or print any of the tests imported or transferred to the PC 511 A00 MU2 REV 2 03 Sibelmed 7 DATOSPIR MICRO User s Manual 189 4 3 EXPORTING TESTS OTHER SYSTEMS The DATOSPIR MICRO spirometer can export the tests saved previous to the Internal Database to other management systems in each hospital The equipment shows the information in comma delimited mode making it compatible with many different systems The information is available in the following files PRUEBAS CSV Contains the
8. 2 back to the Standard Configuration option and press the key 3 Your Standard Configuration has now been memorised Should you need to modify a customisation option during a test it can be accessed manually and modified The Standard Configuration can be restored at any time To do so press the key 511 00 02 2 03 Sibelmed 7 DATOSPIR MICRO User s Manual 109 COMMON CUSTOMISATION This option customises certain suboptions that are common to any test made using the DATOSPIR MICRO 83 8686 COMMON CUST 16 05 8 03 06 06 COMMON CUST 16 03 mum rl Sets the internal equipment clock time and date coo ABC or 800 Mode alphanumeric or numeric Battery type alkaline or NiMh or This selection only affects the calculation made inside the equipment to indicate the battery level Operating language Enter a heading in the report This allows inserting two heading lines with a maximum of 33 characters line This can include the name of the hospital the doctor etc and will appear in each report Printer type Protection customisation PIN 511 A00 MU2 REV 2 03 2 pue sjapow 1o3deu Sibelmed DATOSPIR MICRO User s Manual 110 PULSE OXIMETRY CUSTOMISATION The SpO module is an option included in the DATOSPIR MICRO Each user should customise it to suit their needs
9. There are two bases with the same functions but different capacities Database L Database H The tests that can be saved using a six second FVC as reference are Database L 150 Database H 21000 The saving of the tests has already been described in the sections corresponding to each test The database always saves all the spirometric parameters of each of the different test modalities FVC VC MVV or Dilation despite them not being selected in the Customisation programme Different functions are possible from the spirometer 1 Search the database 2 Search for a patient 511 A00 MU2 REV 2 03 Sibelmed 7 DATOSPIR MICRO User s Manual 77 Search for a register 4 Print a summarised report 5 Delete the database To do so start the DATOSPIR MICRO using the key and wait for the following screen to appear MAIN MENU 1 Spirometry Using the or v keys select the option MAIN MENU 3 Database Press the key gt and with or v select the required function DATABASE SEARCH The DATOSPIR MICRO displays the parameters saved in the database for each test If this is to be carried out on a regular basis use the W20 Spirometry Software to conveniently view all the saved parameters 511 A00 MU2 REV 2 03 y 4 Chapter 2 Model Operating S belmed 7 DATOSPIR MICRO User s Manual 78 Select the option DATABASE 1 Search DB
10. MVV TEST PROCEDURE 65 2 7 POST BRONCHIAL DILATOR SPIROMETRY PROCEDURE 67 511 A00 MU2 REV 2 03 Index Sibelmed DATOSPIR MICRO User s Manual 4 2 8 CALIBRATION 70 2 9 INTERNAL 2 52 4 76 2 10 MAINTENANCE PROGRAMME 80 2 11 UPDATING INTERNAL 5 87 2 12 HOME MODE 65 91 3 MODELS AND OPERATION 99 3 1 FUNCTION TREE 100 3 2 EQUIPMENT 5 5 105 3 3 EQUIPMENT PROTECTION 112 3 4 FORCED VITAL CAPACITY FVC TEST PROCEDURE FREE 114 3 5 SLOW VITAL CAPACITY VC TEST PROCEDURE 132 3 6 MAXIMUM VOLUNTARY VENTILATION MVV TEST 8 54 a ava ga 134 3 7 POST BRONCHIAL DILATOR SPIROMETRY PROCEDURE i 5 eiie ELRE EXER RR EE TRE R
11. to display the results of the tests saved in the database consult the diagnosis of each one if the option is enabled print a report or delete a test from the database Press the key gt and with v select the option required Pat Code Test 1 Results Pat Code Test 2 Diagnosis Pat Code Test 3 Report Pat Code Test 4 Delete test PATIENT SEARCH Select the option DATABASE 2 Search Pat 511 A00 MU2 REV 2 03 S be med 7 DATOSPIR MICRO User s Manual to search for a patient in the database Press the key gt and enter the patient code REGISTER SEARCH Select the option DATABASE 3 Search Reg to search for a register in the database Press the gt key and enter the register number SUMMARISED REPORT Select the option DATABASE 4 Summ Report to print a report with the list of tests saved in the database Press the key gt DELETE DATABASE Select the option DATABASE 5 Delete DB to delete the entire database Press the key gt 511 A00 MU2 REV 2 03 y 4 Chapter 2 Model A Operating Sibelmed 7 DATOSPIR MICRO User s Manual 80 2 10 The equipment has maintenance programme to adjust and or check the working order of certain options From the Main screen press keys or v to choose MAIN MENU 5 Maintenance Press the key gt to acce
12. 2 03 S be med 7 DATOSPIR MICRO User s Manual 205 5 6 1 SIMBOLOGY uo 9 BEBO DES SERIAL NUMBER MANUFACTURER The date of manufacture name and address of manu facturer TEMPERATURE LIMITATION HUMIDITY LIMITATION PREASURE LIMITATION DIRECTIONS FOR US NOT ALARMA SpO LOT EXPIRY DATE CAUTION 511 A00 MU2 REV 2 03 suoneoyi2eds 6 193deu Chapter 5 Technical Specifications S belmed DATOSPIR MICRO User s Manual 206 2 O 4 BIC DISPOSAL OF WASTE ELECTRICAL ELECTRONIC AGREEMENT TO THE WEE DIRECTIVE DO NOT REUSE IPX1 START UP STANDBY BF APPLIED PART B APPLIED PART 511 A00 MU2 REV 2 03 Sibelmed 7 DATOSPIR MICRO User s Manual 207 6 OPERATING PRINCIPLES 511 00 02 REV 2 03 9 4 Chapter 6 Operating Principles Sibelmed DATOSPIR MICRO User s Manual 208 The DATOSPIR MICRO spirometer is a piece of equipment that acquires physical signals and processes the information provided by the signal related to the pulmonary function For processing purposes physical must be changed to electrical The units responsible for this change are called transducers The DATOSPIR MICRO has a Turbine type transducer The turbine transducer performs transduction in two stages The volume to be measured crosses the turbine and prints its rotation that is proportional to that volu
13. 511 00 02 REV 2 03 Chapter 2 Model A Operating S belmed DATOSPIR MICRO User s Manual 34 of the sections in this Chapter except for 2 12 HOME MODE OPERATIONS refer to HOSPITAL MODE 2 1 FUNCTION TREE The DATOSPIR MICRO spirometer function tree is shown for a better understanding of its structure This structure corresponds to Model A and is characterised by the fact that it contains text menus The DATOSPIR MICRO Model A has 4 silicon keys located underneath the screen to move around the different menus in the equipment In general the and v keys enable you to move around the different menu options The gt key provides access to the selected option the lt key takes you back to the previous menu The following can be accessed from the Main Menu depending on the options included SPIROMETRY CALIBRATION DATABASE CUSTOMISATION MAINTENANCE OPERATING MODE BLUETOOTH 1 5 1 Forced Vital Capacity Test 1 Start manoeuvre 2 Results 511 A00 MU2 REV 2 03 Sibelmed 7 DATOSPIR MICRO User s Manual 3 4 5 6 7 8 Diagnosis Save DB Save PRE Report Delete New patient Slow Vital Capacity Test Start manoeuvre Results Save DB Save PRE Report Delete New patient IS NO Ui A UN HO 3 MVV Maximum Voluntary V
14. 7 SPIROMETRY TECHNIQUE or ask for a spirometry course from SIBEL S A Patients can carry out the spirometry manoeuvres in two different ways e first consists of starting to move the turbine with FORCED EXPIRATION followed by FORCED INSPIRATION if required e second consists of the patient breathing normally through the turbine and when indicated by the technician fill his lungs full of air and then start FORCED EXPIRATION followed by FORCED INSPIRATION if required Inform the patient of the way of holding the equipment when using the spirometer taking care not to press any key and fitting the nose clip as shown in the following figure 511 A00 MU2 REV 2 03 y 4 Chapter 2 Model A Operating Sibelmed 7 DATOSPIR MICRO User s Manual 48 5 4 Select the screen 1 Start Manoeuv press the gt key The following screen will appear MEASURING The equipment is held so that the doctor can see the screen while the patient is carrying out the tests On the left hand side is a rectangle indicating that the equipmen is ready for the test to be started The patient has 30 seconds to begin After this time if he has not started the equipment will Switch to standby and must be pressed again After the expiratory manoeuvre the second line of the screen will show a bar movement of which is proportional to the volumen of the expiratory man
15. FVC TEST 1 Start Manoeuvre Allows for spirometric manoeuvres to be acquired FVC TEST 2 Results Displays the results of the best three manoeuvres FVC TEST 3 Diagnosis Displays the diagnosis according to the results obtained FVC TEST 4 Save DB Saves the selected manoeuvre to the Database 511 A00 MU2 REV 2 03 y 4 Chapter 2 Model A Operating Sibelmed 7 DATOSPIR MICRO User s Manual 46 FVC TEST 5 Save PRE Saves in the Database as PRE FVC TEST 6 Report Prints the report on any completed manoeuvre FVC TEST 7 Delete Deletes any manoeuvre FVC TEST 8 New Patient Option to change patient or to change some datails of an existing patient ENTERING FORCED VITAL CAPACITY TESTS The technician to carry out the forced spirometry tests must know the normal procedures required so that the patient can be coached Where this is not the case certain documentation on the matter must be reviewed 511 00 02 REV 2 03 Sibelmed 7 DATOSPIR MICRO User s Manual 47 When undertaking spirometry take the following steps into account 1 Check that the turbine is correctly inserted with the mouthpiece as in the figure INSERT FIRMLY oe 2 Instruct the patient as to how to carry out the test as his cooperation is vital for it to be completed correctly WARNING The test must be carried out by skilled staff Review Chapter
16. It is advisable to use the device in an acoustic environment enough silent to allow the patient make the manouvers correctly and hear the acoustic warnings The device must be located in a safety position This avoids it falls down and consequently any failure to the device or damage to patient and or user In hospital mode the DATOSPIR MICRO is a complete spirometer and users may fully configure the instrument In home mode patients may only switch the equipment on blow and switch it off The doctor must have previously configured this mode before prescribing use of the instrument PULSE OXIMETER Optional This oximetry sensor should be used by a physician or under the supervision of medical staff 511 A00 MU2 REV 2 03 Safety 6 DATOSPIR MICRO User s Manual The pulse oximeter does NOT require calibration The pulse oximeter has NO physiological alarms Pulse oximeter probes do NOT allow temporary immersion The pulse oximeter waveform is NOT normalizzed Patient movements or excessive lighting can affect the accuracy of the device The pulse oximetry module has CE marking and can not reach temperatures gt 42 9 The clinical validated sensors to be used with NONIN pulseoximetry module XPOD 3011 are NONIN sensors Oxygen saturation and heart rate measures must be performed using these sensors otherwise there may be significant measurement errors The wavelengths used are 66
17. Minimum Saturation value Std SpO Standard Saturation Deviation PR Maximum pulse rate value Average PR Average pulse rate value PR Minimum pulse rate value Standard pulse rate deviation Useful test time when the finger clip is disconnected is not considered CALIBRATION Calibration programme for dynamic tests with syringe of 1 to 6 litres in volume Register of the latest calibrations Where required calibration warning CUSTOMISATION PROGRAMME User selected STANDARD configuration Customisation of the language printer and report heading etc 511 A00 MU2 REV 2 03 Sibelmed 7 DATOSPIR MICRO User s Manual 197 Spirometry customisation Parameters of reference Observed parameters Graph selection Diagnosis selection Report customisation Pulse oximetry customisation INTERNAL DATABASE Saving of spirometric and pulse oximetry tests Two types of database according to their storage capacity CLOCK CALENDAR Hour Minute Second Day Month Year 5 2 MEASURING SYSTEM TYPE OF TRANSDUCER Turbine type transducer with axial type two way volumetrics with opto electronic rotary sensor that is detachable for cleaning and sterilisation Rotation is made on saphire bearings for high reproduceability and duration 511 A00 MU2 REV 2 03 suoneoyi2eds 6 193deu Chapter 5 Technical Specifications Sibelmed 7 DATOSPIR MICRO User s Manual 198 RANGES AND MEASUREMENTS T
18. Sibelmed DATOSPIR MICRO SIBEL 5 ROSSELLO 500 08026 BARCELONA PRUEBA DE FUNCION PULMONAR DATOSPIR MICRO C digo 0000000001 06 04 2006 11 34 Nombre Hombre Edad 27 Talla cm 174 Peso Kg 68 Temp C 26 Pres mmHg 760 Humedad 60 0 Referencias SEPAR F Etnico 100 Motivo Procedencia T cnico Ver Bios 5115AB 1 00 Ver Prog 5115AF 1 00 INFORME DE FVC MANIOBRA N 1 1 PARAMETRO PRE REF POST SP Mejor FVC 5 00 5 35 93 5 99 18 Mejor 1 4 57 4 27 107 4 26 6 FVC 1 5 00 5 35 93 5 99 18 1 4 57 4 27 107 4 26 6 FEVL FVC 91 57 80 44 114 73 17 24 PEF 1 8 9 87 10 11 98 6 50 40 MEF50 6 16 5 52 112 3 78 47 FEF25 75 1 8 5 69 4 50 126 3 42 49 FEVI FEVO 5 1 30 1 45 90 1 55 17 3 7 72 6 64 116 10 93 34 Comentarios EU Rd resa 511 A00 MU2 REV 2 03 1 Chapter 2 Model A Operating Sibelmed 7 DATOSPIR MICRO User s Manual 70 2 8 CALIBRATION PROCEDURE GENERAL OBSERVATIONS The Normative in force regarding spirometry recommends that all spirometers be perfectly calibrated This is due to the alterations that may modify the characteristics of the electronic circuits and mechanical aprts over time and cause a change in the spirometer calibration factors Hence a calibation system has been incorp
19. The different options included in the Customisation menu are explained in detail in the previous section To access this option press CUSTOMISATION the main menu The following screen will appear CUSTOMISATION 16 05 m a a ct Exits this screen and goes back to the previous one Standard Configuration a Home mode customisation cH E Database customisation Common customisation Spirometry customisation Pulse oximetry customisation v 21 511 A00 MU2 REV 2 03 uonesdo 2 pue g sjapow 1oe3deu Chapter 3 Models B C Operation Sibelmed DATOSPIR MICRO User s Manual 106 SPIROMETRY CUSTOMISATION This option customises any suboptions specific to the spirometric tests 83 66 SPIROMETRY CUST 16 06 ESC l Parameters of Reference Allows selecting among several Selects for children and adults Prioritises the age range selected for adults if a different table is chosen for children Extrapolates the values for the ages outside the selected table range Observed Parameters Allows for the observed parameters or measured parameters you want to use to be selected This is only at display level or for the report All the parameters are saved on the database and can be enabled at any time E Selecting the graph type HE Diagnosis Selection according to Miller Quadrant Snider Kory amp Lyons Algorithm
20. The one with the best FEV1 is considered the best e The curves with warnings ET EX are considered the worst 5 Asa guideline for subsequent control and diagnosis patients can note down where applicable one or several of the different symptoms during the test COUGH PANTING BREATHING DIFFICULTIES or MUCOSITY The severity can be chosen for each symptom from among the following values NONE No symptom LOW MEDIUM HIGH IMPORTANT NOTE Proceed as follows to go from HOME MODE to HOSPITAL MODE Stop equipment with the key Keep the keys v and gt pressed down at the same time and restart by pressing 511 A00 MU2 e REV 2 03 y Japow 4 Chapter 2 Model A Operating Sibelmed 7 DATOSPIR MICRO User s Manual 98 The following warning will appear on screen after a few seconds RELEASE THE KEYS You should then release keys gt The spirometer is now in HOSPITAL mode DISPLAYING SAVED INFORMATION The information saved can be displayed on the DATOSPIRMICRO spirometer or on the PC using the W20 Spirometry Software In both cases the aforementioned options can be chosen consulting parameter printing a report etc 511 A00 MU2 REV 2 03 Sibelmed 7 DATOSPIR MICRO User s Manual 99 3 MODELS B OPERATION 511 A00 MU2 REV 2 03 2 pue g sjapow Chapter 3 Models C Operation
21. To save power the equipment includes an auto switch off system that turns the equipment off when not touched for 5 minutes except in main spirometry and pulsioximetry screens In this case the data on the screen is lost and the normal process must be followed to restart the equipment 511 00 02 REV 2 03 5 DATOSPIR MICRO User s Manual 27 In models B and C in order to save power Lcd backlight will be switched off if the equipment is not used in 20 seconds WARNING When inserting the batteries for the first time or when changing them the equipment may switch on automatically This is normal and does not indicate any type of malfunctioning Atmospheric conditions The atmospheric working conditions are e Atmospheric temperature between 5 and 40 C The American Thoracic Society recommends 17 to 40 C e Relative humidity below 95 without condensation e Atmospheric pressure from 525 to 800 mmHg Between 699 9 and 1066 7 hPa from approx 3000 to 400 metres Location Take care not to place the equipment where it could be splashed by water or other liquids or cover it with objects that prevent air from circulating around it while it is running Once the batteries have been inserted and the equipment is in a suitable place it is ready to begin operating USB MODULE INSTALLATION The equipment includes a Microcontroller exclusively for USB control which is ready for use For use with a P
22. different absorption of certain wave lengths red and infrared through the arteries depending on the amount of Haemoglobin transported by the red cells The wave lengths used are 660 nm for red and 910 nm for infrared 511 A00 MU2 REV 2 03 9 193deu 5 Chapter 6 Operating Principles Sibelmed DATOSPIR MICRO User s Manual 212 511 A00 MU2 REV 2 03 S belmed DATOSPIR MICRO User s Manual 213 7 SPIROMETRY TECHNIQUE 511 A00 MU2 REV 2 03 enbiuu o 9 Technique T Spirometry Sibelmed DATOSPIR MICRO User s Manual 214 7 1 PROCEDURE The following is an extract from the STANDARD FOR FORCED SPIROMETRY SEPAR Recommendations No 1 Forced spirometry will be performed with the patient seated upright with the nose occluded by clips The technician will rest his hand on the patient s shoulder to prevent him from leaning forwards during expiration The mouthpiece will keep its shape to prevent the hole from being reduced due to biting during forced expiration Soft mouthpieces must be shortened to increase their consistency Spirometry always involves a minimum of three forced expiration manoeuvres and a maximum of eight when not considered suitable Exceeding this limit leads to the needless tiring of the patient and a loss of the technician s time To assess the spirometry performed lying down remember that un
23. 051E 4 30 0 789 0 651 PEF 0 075 0 275E 9 08 0 907 1 073 0 073 0 134E 7 57 0 879 0 831 FEF 5096FVC M 0 017T 0 157E 0 029P 2 17 0 856 0 811 0 046 0 067E 4 17 0 803 0 669 FEF 75 FVC 0 024 0 066E 2 61 0 760 0 562 0 027 0 032E 2 68 0 709 0 507 Variable Sex Equation Age 20 70 R SEE FVC M 0 0678T 0 0147E 6 05 0 72 0 530 F 0 0454T 0 0211E 2 83 0 75 0 403 FEV1 M 0 0499T 0 0211E 3 84 0 75 0 444 F 0 0317T 0 0250E 1 23 0 82 0 307 FEV1 FVC 0 1902 85 58 0 224 0 1126 94 88 FEF 25 75 0 0392 0 0430E 1 16 0 55 1 000 F 0 0230 0 0456E 1 11 0 70 0 680 PEF M 0 0945 0 0209E 5 77 0 47 1 470 F 0 0448 0 0304E 0 35 0 47 1 040 FEF 5096FVC 0 0517T 0 0397E 2 40 0 47 1 300 F 0 0242T 0 0418E 1 62 0 56 0 925 FEF 2596FVC 0 0190T 0 0356E 0 14 0 63 0 620 F 0 02 0 031 0 0062 0 21 0 76 0 405 6 64 7 77 FEV1 FEVO 5 1 45 1 50 FEF50 FIF50 0 66 0 88 PEF PIF M 1 39 F 1 42 FEV1 FIV1 M 0 80 F 0 89 511 A00 MU2 REV 2 03 S belmed DATOSPIR MICRO User s Manual 219 M male F female R multiple correlation coefficient SEE typical estimate error T height cm P weight Kg E age years The parameters with an asterisk are not listed in the SEPAR standard 7 4 VALUES OF REFERENCE FOR FORCED SPIROMETRY ECCS 93 Standardized Lung Function Testing Offic
24. 15 litres whichever is highest The technician performing the spirometry may where considered appropriate disable these warnings in the Customisation Programme In this case they will also be removed from the printed report This disabling is only at display level The warnings are still taken into account when ordering the manoeuvres ATTENTION Check in the Customisation Programme that the REFERENCES and the ETHNIC FACTOR are suitably selected The ethnic factor modifies the value of the References according to the percentage selected 100 is equivalent to the unmodified standard value of the References Perform new spirometric manoeuvres Sibelmed 7 DATOSPIR MICRO User s Manual 121 e The new graph is superimposed to compare it with the best 1 dotted line of those saved e As many manoeuvres as required can be carried out The DATOSPIR MICRO will always save the five best for FVC and VC and the three best for MVV according to ATS ERS criteria e The different regulations recommend at least three satisfactory manoeuvres in which the repeatability criterion is complied with but no more than eight as this would tire the patient e Thelast manoeuvre entered remains flashing and corresponds to the continual line graph Where more than five manoeuvres have been entered and none are flashing this indicates that the last entered is worse than the five saved and will be deleted e three or more manoeuvr
25. 7 5 OTHER VALUES OF REFERENCE Based on Separ and Ceca references the spirometer has the following references Knudson Crapo Zapletal Morris Austria Gutierrez Chili Castro Brazil Polgar Weng Hankinson NHNES Perez Padilla Mexico A J Cruz Mexico Golshan Iran 511 00 02 REV 2 03 DATOSPIR MICRO User s Manual 221 s 8 UPKEEP PREVENTATIVE AND CORRECTIVE MAINTENANCE 511 A00 MU2 REV 2 03 9An294405 pue 8 4 4 Chapter 8 Upkeep Preventative and Corrective Maintenance Sibelmed 7 DATOSPIR MICRO User s Manual 222 Like any equipment particularly if for medical applications the DATOSPIR MICRO spirometer requires upkeep and maintenance aimed firstly at the safety of patients operators and the environment and secondly at ensuring the reliability and precision of the functions for which it has been developed All this leads to a series of routines that must be completed 8 1 UPKEEP Upkeep is aimed at ensuring the correct working order of the equipment The person undertaking it requires no special technical skills except knowledge of the functions and handling of the equipment The equipment user himself must normally perform this The operations to be completed are as follows CLEANING THE TURBINE TRANSDUCER Given that the turbine is the part exposed directly to t
26. 8123456783 6 Techs Sur 100 Yrs kg Age L onl amp mkI 81 cdl ze hun ve Me 01234 321 e 7 The meaning of each field is as follows Cod Code 10 character numeric or alphanumeric field depending on the customised option corresponding to the patient code Tec Technician 10 character numeric field corresponding to the code of the technician carrying out the test 511 A00 MU2 REV 2 03 Sibelmed 7 DATOSPIR MICRO User s Manual 115 Yrs Age Number corresponding to the age between 4 and 100 cm Height Height in cm between 50 and 230 kg Weight Weight in kg between 15 and 200 2 Sex Between male and female C d Cigarettes day Between 0 and 100 cigarettes SmkI Smoker index Between 0 and 200 packets a day multiplied by the number of years The Smoker Index is the same as the number of cigarettes smoked a day divided by 20 and multiplied by the number of years smoking cigarettes day x years smoking 20 EtF Ethnic factor Between 80 and 120 The ethnic factor is used in areas without their own reference parameters and using some which exist but which are corrected to a specific percentage This factor MUST BE SET TO 100 IF NOT USED and can only be modified through the Customisation Programme Nam First name 20 character alphanumeric field corresponding to the patient
27. A00 MU2 REV 2 03 5 DATOSPIR MICRO User s Manual 227 EUN APPENDIX 1 ELECTROMAGNETIC COMPATIBILITY 511 A00 MU2 REV 2 03 1223 T xipueddy Electromagnetic Compatibility Appendix 1 Sibelmed 7 DATOSPIR MICRO User s Manual 228 Guidance and manufacturer s declaration electromagnetic emissions DATOSPIR MICRO is intended for use in the electromagnetic environment specified below The customer or the user should assure that it is used in such an environment Emissions test Compliance Electromagnetic environment Guidance RF Radiated emissions Group 1 DATOSPIR MICRO uses RF energy only for its internal function Therefore its RF emissions are CISPR 11 EN 55011 Class B very low and are not likely to cause any interference in nearby electronic equipment RF Conducted emissions Not applicable DATOSPIR MICRO works with batteries DC USB CISPR 11 EN 55011 Harmonic emissions Not applicable DATOSPIR MICRO works with batteries DC USB EN IEC 61000 3 2 Voltage fluctuations Flicker Not applicable DATOSPIR MICRO works with batteries DC USB emissions EN IEC 61000 3 3 511 A00 MU2 REV 2 03 Sibelmed 7 DATOSPIR MICRO User s Manual 229 Guidance and manufacturer s declaration electromagnetic immunity DATOSPIR MICRO is intended for use in the electromagnetic environm
28. FvCref X By pressing or respectively you can change diagnosis 511 A00 MU2 REV 2 03 J pue sjapow 1oe3deu Sibelmed DATOSPIR MICRO User s Manual 126 MEMORISING FVC TESTS Memorising a test in the Internal Database The DATOSPIR MICRO spirometer has an Internal Database that can save different tests which are subsequently transferred to a PC Database This base may be of the L or depending on its capacity The manoeuvre selected by default is the best M1 If you want to save another it must first be selected Once the manoeuvre to be saved on the database has been selected on the test screen press the key The following screen will appear PVE REF 15 45 4 36 Mi 5 42 3 88 14 22 3 58 Sd 3 3 38 pref 7 Press the key The following message will appear indicating that the manoeuvre has been saved 1 21 1 46 45 82 06 TE d lel tot ai 4 7 IREF 5 45 4 38 PT DM 15 42 3 58 aM2 14 22 3 50 5 4 2 MANOEUVRE Mo 4 SAVED 2 Sibelmed DATOSPIR MICRO User s Manual 127 Memorising a test to compare it in POST bronchial dilation mode This options allows for a test to be saved in PRE bronchial dilation mode to then compare it with POST bronchial dilation mode The process is similar to that described above Once the manoeuvre to be saved on the data
29. PRE POST PRE See J E Cotes Lung Function Assessment and Aplication in Medicine Blackwell Sci 4th Edition 1979 p52 53 The registering of parameters and graphs is as shown below 511 A00 MU2 REV 2 03 Sibelmed 7 DATOSPIR MICRO User s Manual 139 Sibelmed TATOS ATR STERT ROSZELLUC 500 BARCELONA PULMONARY FUNCTION rsen LEA LES RISO Ober Code Date 04 06 2006 Time 2 24 Mame Som Mato age Hei ght fom 17a Wt 46 Pica annal 75D Mumidity Siok T 0 SEPAR Ethnic 15 190 Technician Dios Ver 5115 1 00 Prog Ver 51ISAF 1 REPORT MANORIVEE No 1 1 PS RAMEE Re PRE er Punk MUI 1 5 35 5 239 18 nest 1 4 27 107 4 26 6 puc 1 5 00 5 35 5 99 1 4 7 4 27 107 4 26 6 21 57 g d 114 71 17 24 M 3 83 5 40 4 MEPS amp l 5 52 112 2 78 47 FSS 1 5 52 4 50 126 3 42 0 FEVIL LLVO 5 Xu l 45 90 1 55 iT pH ix Te 10 83 14 2 22 2222 222 An 511 A00 MU2 e REV 2 03 2 pue sjapow Chapter 3 Models C Operation Sibelme d DATOSPIR MICRO User s Manual 140 3
30. REV 2 03 32 z xipueddy Appendix 2 Compliance with the Data Protection Act Sibelmed DATOSPIR MICRO User s Manual 234 COMPLIANCE WITH THE DATA PROTECTION ACT DIRECTIVE 95 46 EC Requirements specifically affecting the use of the DATOSPIR MICRO Spirometer This section seeks to ensure user compliance with the current data protection legislation in relation to the use of this equipment A brief description is given as to how the DATOSPIR MICRO Spirometer must be handled to comply with the requirements of this act IMPORTANT WARNING e According to current legislation the user of this equipment is the only party responsible for saving and processing the details of his patients according to the Law e Observance of the recommendations included in this section under no circumstances guarantees the full adaptation of the user s activity to the data protection regulation Configuration of the DATOSPIR MICRO Protection The DATOSPIR MICRO spirometer has an equipment protection option that uses a password or pin This option is user configurable and seeks to prevent access by unauthorised people to the equipment and more specifically to the private data it contains To comply with current legislation users must enable this option and configure their pins They will be held responsible for providing this pin to the authorised people 511 A00 MU2 REV 2
31. TIME mode Saving of three manoeuvres from the same test 511 A00 MU2 REV 2 03 Sibelmed 7 DATOSPIR MICRO User s Manual 195 MAXIMUM VOLUNTARY VENTILATION Parameters e MVV l min Maximum Voluntary Ventilation e Br min Br min Breathing frequency of MVV Percentage deviation in relation to values of reference Standardised values of reference that can be selected from several standards Patient s ID details Atmospheric data on temperature pressure and relative humidity Graphs in VOLUME TIME mode Saving of five manoeuvres from the same test POST BRONCHIAL DILATION TEST Same parameters and characteristics as in FVC Several methods of comparison among PRE POST and REF values Superimposing of PRE and POST graphs SpO PULSE OXIMETRY The DATOSPIR MICRO allows for specific or long term measurements lasting for 8 hours 511 00 02 e REV 2 03 6 193deu Chapter 5 Technical Specifications 5 7 DATOSPIR MICRO User s Manual 196 Parameters CT90 CT80 CT70 IDH 4 IDH 3 IDH 2 Maximum Minimum Maximum Minimum Std PR Test Time of time in which SpO is below 90 of time in which SpO is below 80 of time in which SpO is below 70 Desaturation index gt 4 per hour Desaturation index gt 3 per hour Desaturation index gt 2 per hour SpO Maximum Saturation value Average SpO Average Saturation value SpO
32. Temp 26 Pres mmHg 760 Humidity 60 Smok I 0 References SEPAR Ethnic 100 Reason Origin Technician Bios Ver 5115 1 00 Prog Ver 5115 1 00 VC REPORT MANOEUVRE No 1 1 PARAMETER OBS REF 1 3 36 08 2 IT ERV NE 0 72 CURELE snae nodes ro karen ue s a da Ea WE Ee dee ev S e dU o dim aw mm 511 A00 MU2 REV 2 03 Chapter 3 Models Operation PLA DATOSPIR MICRO User s Manual 134 3 6 TEST PROCEDURE The procedure to carry out the Maximum Voluntary Ventilation MVV test is similar to that described in section 3 4 FORCED VITAL CAPACITY FVC PROCEDURE with the following variations 1 Access the test by pressing the key from the main screen and perform a manoeuvre 481 52 167 78 44 12 481 52 CJ 167 78 44 12 0 2 axes are displayed in VOLUME TIME mode Instruct the patient as to how to the test is being carried out as his cooperation is vital for it to be completed correctly 4 The maximum time allowed for the manoeuvre is 15 seconds The equipment saves a maximum of three manoeuvres ordered according to the MVV value where M1 is the best MVV and M3 the worst 5 registering of parameters and graphs is as shown below 511 A00 MU
33. an internal database and subsequently transferred to the PC database for data analysis and storage HOSPITAL MODE This option means that the DATOSPIR MICRO can be used as a sophisticated spirometer with the following functions Spirometry Patient Details Reference Age Weight Height Sex Index Smoker Atmospheric Conditions Temperature Pressure Humidity Tests FVC VC MVV Bronchial Dilation Report e Customisation selectable options Spirometry References Parameters Graphs Diagnosis Dilation Modes Warnings Home mode Patient details test data Printers Standard curves Retrieve standard modify standard Battery Language Set clock Time Date Pulse oximetry e Calibration e Internal Database to save tests with alphanumeric and graphical data depending on model e Maintenance Warnings 511 A00 MU2 REV 2 03 pue esr 10J 2 15 T 1e3deu Chapter 1 Instructions for Use and Installation Sibelmed DATOSPIR MICRO User s Manual LCD contrast Equipment check Equipment configuration ATS curves Function modes Home Hospital Pulse oximetry When the quality of the signal is low or the finger is not present the SpO2 values are set to zero to avoid showing incorrect values Bluetooth 511 A00 MU2 REV 2 03 Sibelmed 7 DATOSPIR MICRO User s Manual 33 lt lt 2 2 MODELA
34. appear 511 00 02 REV 2 03 Sibelmed 7 DATOSPIR MICRO User s Manual 179 PRESS gt gt START TEST and the equipment will issue a beeping sound every 10 seconds If for 2 minutes the equipment is not pressed it will switch off Press the key 2 The following screen will appear Ls The patient can start the manoeuvre after the arrow has appeared they have 30 seconds 511 A00 MU2 REV 2 03 J pue sjapow 1oe3deu Chapter 3 Models B C Operation PLA DATOSPIR MICRO User s Manual 180 patient must perform three expiratory manoeuvres and the following screen will appear VALUE IM RELATION TO SEMAPHORE MEDIUM MINIMUM MAKSIMUM Indicates the value of the manoeuvre in relation to the semaphore low medium or good The equipment automatically saves the best manoeuvre in the memory according to the following criteria e The one with the best sum of FVC is considered the best e The one with the best FVC is considered the best e The one with the best FEV1 is considered the best e Thecurves with warnings ET EX are considered the worst 4 Asa guideline for subsequent control and diagnosis patients can note down where applicable one or several of the different symptoms during the test COUGH PANTING BREATHING DIFFICULTIES or MUCOSITY The severity can be chosen for each
35. criteria whether they are at home or in hospital In this option the spirometer is extremely user friendly equipment as the sequence of instructions on the screen will guide patients during spirometric manoeuvres In turn it automatically saves the best manoeuvres made in the different tests to memory This enables the specialist to subsequently analyse them and make the corresponding diagnosis It is also possible to transfer them from the equipment Database to the PC Database using W20 Spirometry Software Three stages can be described for a better understanding of this operating mode 1 Spirometer configuration 2 Acquisition of spirometric tests Displaying of the information saved CONFIGURATION The specialist must configure the spirometer in HOME mode and provide the patient with the necessary instructions The process to follow is as described below Start the DATOSPIR MICRO using the key and wait for the following screen to appear MAIN MENU 1 Spirometry 511 A00 MU2 REV 2 03 y 4 Chapter 2 Model A Operating Sibelmed 7 DATOSPIR MICRO User s Manual 92 Using the or 7 keys select the option MAIN MENU 4 Customise and then CUSTOMISATION 2 Home Mode Home mode customisation includes the customisation of the patient s details and the test data Select HOME MODE 1 Patient Details and enter the data requested on the successive screens PAT
36. database tests PATIENTS CSV Contains the database patients GRAFxx CSV Contains the graphs in Flow Time mode The graph file as indicated contains the graphs for each test in Flow Time mode If you want to display the graphs in Volume Time or Flow Volume mode in the new management system the following aspects must be taken into account e The Flow signal with the turbine type transducer is sampled at 50Hz e The ratio of the axes in the Volume Time graph must be adjusted to 1 litre 2 seconds e The ratio of the axes in the Flow Volume graph must be adjusted 2 1 5 1 In the event of doubt or queries contact the SIBEL S A Technical Service or your distributor who will provide any further information you may require 511 A00 MU2 REV 2 03 Waj SAS suorme2iunululio 1o3deu Chapter 4 Communications system Sibelmed 7 DATOSPIR MICRO User s Manual 190 4 4 SPIROMETRY SOFTWARE W 20 FOR PC See the W 20 Spirometry Software User s Manual for all related information 511 A00 MU2 REV 2 03 Sibelmed 7 DATOSPIR MICRO User s Manual 191 D TECHNICAL SPECIFICATIONS 511 A00 MU2 REV 2 03 suomne 2yi oeds 6 Chapter 5 Technical Specifications S belmed DATOSPIR MICRO User s Manual 192 The specifications given below are applicable in each case depending on the model available as indicated in detail in Section 1 3 SPIROMETER MODELS 5 1 TYPES OF TE
37. forwards through the registers 511 A00 MU2 REV 2 03 2 pue g sjapow 1oe3deu Chapter 3 Models C Operation Sibelme d DATOSPIR MICRO User s Manual 160 The movement value is configured in the Customisation menu Deletes the test selected Displays the test selected 4 and Moves around the different tests Select a test and press The following screen is accessed IREF 15 50 4 39 15 42 3 88 ESC Go back to the previous screen Display test data Display the test diagnosis Print the test e Pressing the axes changes the type of graph Flow Volume or Volume Time 511 A00 MU2 REV 2 03 Sibelmed 7 DATOSPIR MICRO User s Manual 161 e Pressing the graph area makes the buttons disappear and makes it larger or smaller PATIENT SEARCH Select the option to search for a patient the database The following screen will appear FATIEMT SEARCH 2 3 4 Enter the patient code and press If the patient exists the database search screen will appear Where this is not the case the following warning message will appear PATIENT CODE NOT FOUND REGISTER SEARCH Select the option Al to search for a register in the database The following screen will appear 511 00 02 REV 2 03 SI POW 4 pue
38. gt 3 per hour IDH 2 Desaturation index gt 2 per hour e Maximum Spo Maximum Saturation value e Average SpO Average Saturation value e Minimum Spo Minimum Saturation value e Std SpO Standard Saturation deviation e Maximum PR Maximum pulse rate value e Average PR Average pulse rate value e Minimum PR Minimum pulse rate value e e Std PR Standard pulse rate deviation Test Time Useful test time when the finger clip is disconnected is not considered NOTE Any time during which the finger clip is disconnected is not taken into account when calculating the parameters and Test Time To obtain a report on the study performed press 511 00 02 REV 2 03 Sibelmed 7 DATOSPIR MICRO User s Manual 149 DATOSPIR MICRO SIBEL S A ROSSELLO 500 08026 BARCELONA PULSE OXYMETRY TEST Code 0000000001 Name Sex Male Reason Origin Technician Bios Ver 5115AB 1 00 PARAMETER OBS CT90 25 6 CT80 13 4 CT70 8 0 IDH 4 10 3 IDH 3 18 3 IDH 2 24 3 SpO2 97 0 02 93 3 5 02 81 0 5 2 Std 3 2 BPM Max BPM 125 0 BPM Med BBM 75 6 BPM Min 65 0 BPM Std BPM 12 8 Test Time 02 01 12 DATOS Date 03 2 26 Height cm Prog Ver Sibelmed PIR MICRO 2 2006 Time 18 01 174 Wt Kg 68 5115AF 1 00 511 A00 MU2 REV 2 03 4 2 pue
39. of the electronic medical devices This is a medical electronic device and as such it needs special precautions regarding 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 This symbol on the product indicates that you cannot dispose of the product with domestic waste D ool However any removal of this type of waste is the responsibility 511 A00 MU2 REV 2 03 Sibelmed 7 DATOSPIR MICRO User s Manual 15 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 distribut
40. option 511 A00 MU2 REV 2 03 Sibelmed 7 DATOSPIR MICRO User s Manual 55 5 4 Press the gt key and similar screen to the following will appear depending on the number of manoeuvres made SAVE DB M1 M2 M3 M4 M5 e manoeuvres are ordered according to ATS ERS criteria with M1 the best and M5 the worst e manoeuvre between brackets M3 indicates the position taken by the last manoeuvre entered e flasing text indicates the manoeuvre selected the best 1 is selected by default Select the manoeuvre to be saved using the keys and appearing between brackets and press gt The following screen will appear for few seconds MANOEUVRE N X SAVED If you have made a mistake or wish to modify the manoeuvre repeat the process 511 A00 MU2 REV 2 03 y 4 Chapter 2 Model A Operating 5 7 DATOSPIR MICRO User s Manual 56 ATS ERS criteria The manoeuvre with least warnings is considered the best ET EX With the same number of warnings the manoeuvre with the highest value sum of FVC FEV1 is considered the best Memorising a test to compare it in POST bronchial dilation mode This options allows for a test to be saved in PRE bronchial dilation mode to then compare it with POST bronchial dilation mode The process is similar to that described above but previous
41. sibelmed DATOSPIR MICRO User s Manual 100 All of the sections in this Chapter except for 3 13 HOME MODE OPERATION refer to HOSPITAL MODE 3 1 FUNCTION TREE The DATOSPIR MICRO spirometer function tree is shown to enable a better understanding of its structure This structure corresponds to Models B and C and is characterised by the fact that it contains graphic menus To move around the different equipment menus DATOSPIR MICRO Models B and C have a pointer to select the icons appearing on screen The character number or letter must also be selected to write in the numeric or alphanumeric fields using the pointer WARNING It is recommendable to use the pointer included with DATOSPIR MICRO SIBEL S A is not responsible for any damage caused where other pointers are used Pointed objects must not be used under any circumstances The following can be accessed from the Main Menu depending on the options included SPIROMETRY CALIBRATION DATABASE CUSTOMISATION MAINTENANCE OPERATING MODE PULSE OXIMETRY DILATION REPORT BLUETOOTH 511 00 02 REV 2 03 Sibelmed 7 DATOSPIR MICRO User s Manual 101 SPIROMETRY e Forced Vital Capacity FVC Test Test data Patient Code Full name Age height weight and sex Smoker index Ethnic factor Atmosphere Temperature Start of the spirometric manoeuvre Graph presentation Flow Volume only in FVC Volume Time Manoeuvre selection Select the best manoeuvre Ma
42. symptom from among the following values e NONE No symptom e LOW e MEDIUM 511 A00 MU2 REV 2 03 Sibelmed 7 DATOSPIR MICRO User s Manual 181 do so press to the next screen HAVE YOU COUGHED NONE MEDIUM HIGH JL IL JE I lt HAVE YOU NOME MEDIUM HIGH OO lt x HAVE YOU HAD BREATHING DIFFICULTIES NONE MEDIUM HIGH AOL 511 A00 MU2 e REV 2 03 uonesdo J pue g sjapow 1oe3deu Chapter 3 Models B C Operation Sibelmed DATOSPIR MICRO User s Manual 182 HAVE YOU MUCOSITY NOME MEDIUM HIGH AOL gt Upon pressing the following screen appear indicating that the test has been saved on the database TEST ACCEPTED Mo OF REGISTERS IMPORTANT NOTE Proceed as follows to go from HOME MODE to HOSPITAL MODE Stop equipment with the key 511 00 02 REV 2 03 Sibelmed 7 DATOSPIR MICRO User s Manual 183 Keep the lower right of the screen pressed down and restart by pressing The following warning will appear on screen after few seconds RELEASE THE KEYS Then release the lower right of the screen The spirometer is now in HOSPITAL mode DISPLAYING SAVED INFORMATION The information saved can be displayed on the DATOSPIR MICRO spirometer or on the PC using the W20 Spirometry Software In both cases the aforementioned options can be chosen cons
43. the following screen or similar will appear if the process was correct CALIBRATED Ve Vi 3 001 lt 2 Calibrated volumes 12 Once the DATOSPIR MICRO has been calibrated press b and the screen will return to the Start Calibration option 511 A00 MU2 REV 2 03 S be med 7 DATOSPIR MICRO User s Manual 75 CALIBRATION REGISTER The spirometer has a register containing the expiratory and inspiratory factors of the last ten calibrations performed This is extremely useful for centres requiring a quality control of the processes they use To access this register select the option CALIBRATION 2 Calibration DB Press gt and using keys a the option required y 4 2 d v access CALIBRATION DB 1 Reg Data Displays the data on the last ten calibrations CALIBRATION DB 2 Delete Reg Deletes the data on the calibrations saved CALIBRATION DB 3 Report Prints the register with the calibrations 511 A00 MU2 REV 2 03 Chapter 2 Model A Operating Sibelmed 7 DATOSPIR MICRO User s Manual 76 2 9 INTERNAL DATABASE The DATOSPIR MICRO has an Internal Database as standard that saves the different tests made using the equipment and subsequently displays them prints them and or transfers them to a PC or other computerised system for storage or management The base information remains even when the equipment is turned off or the batteries are removed
44. the previous section with M1 the best and M5 the worst e The manoeuvre between brackets M3 indicates the position taken by the last manoeuvre entered e flasing text indicates the manoeuvre selected To display the results press gt To select another manoeuvre press the keys or v Therefore the brackets and the flashing text do not have to match On accessing the results of a test the best FVC mFVC and the best FEV1 mFEV 1 will appear first followed by the results of the selected manoeuvre The best FVC and FEV1 values may correspond to any of the available manoeuvres 511 A00 MU2 REV 2 03 5 7 DATOSPIR MICRO User s Manual TYPE OF DIAGNOSIS The DATOSPIR MICRO spirometer has two types of diagnosis that can be selected in the Customisation Programme NOTE If you do not agree with these two criteria do not use them as a reference The diagnosis and the results of the test must always be validated by the specialist e Miller Diagnosis This presents the following information NORMAL RESTRICTIVE OBSTRUCTIVE or COMBINED according to the criteria of the following chart CUADRANTE DE MILLER 8 Restrictivo i Normal be 8 o S N u emm 8 2 1090 120 FUC FUCref gt e Snider Kory amp Lyons Diagnosis This is based on the following criteria If FVC gt 80 of the FVC Reference and FEV1 gt 80 of t
45. 0 nm red and 910 nm infrared and the optical power is about 9 6mW Consult the instructions for use of the probes before use Follow strictly manufacturer s safety instructions as well as those specified in this manual See instructions for use of the sensor to evaluate the toxicity of SpO2 sensor The maximum recommended application s time of an oximeter in the same place is 8 hours The point of placement must be reviewed frequently to determine the position the movement and the skin sensitivity of the patient The reaction to the sensors by the patients may be different depending on their health and skin conditions No adhesive material should be used if the patient has an allergic reaction to it For log term monitoring is recommended to use flexible or disposable sensors 511 00 02 REV 2 03 S be med 7 DATOSPIR MICRO User s Manual 11 The adult sensor is intended for use on people over 12 years old The peadiatric probe is for children between 3 and 12 years Although the adults probes can be used on any pediatric patient whose fingertip reaches the finger stop of the sensor and on whom the sensor fits securely The system can measure pulse and functional oxygen saturation A functional meter can not be used to evaluate the accuracy of pulse oximeter probe or a pulse oximeter monitor USER PROFILE The spirometer is designed to be used by medical staff only being supervised by a physician Specific tra
46. 03 5 7 DATOSPIR MICRO User s Manual 235 Thus when the spirometer is started a pin will be requested and the equipment locked where this pin is entered erroneously three times On restarting the equipment the unlock code PUK provided by the manufacturer upon purchasing the equipment will be requested If this code is not available the equipment will remain locked Other important issues e Printing documents In the event of saving paper printouts containing patient details these documents must be properly stored so that only duly authorised personnel have access to them Furthermore in the event of users deciding to dispose of the printed documents their effective physical destruction must be ensured to avoid unauthorised access thereto Data transmission The DATOSPIR MICRO 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 511 A00 MU2 REV 2 03 py 94 YUM z xipueddy Appendix 2 Compliance with the Data Protection Act Sibelmed DATOSPIR MICRO User s Manual 236 511 A00 MU2 REV 2 03 Sibelmed 7 DATOSPIR MICRO User s Manual 237 aS Dr enne m APPENDIX 3 MODIFICATIONS 511 A00 MU2
47. 2 REV 2 03 Sibelmed 7 DATOSPIR MICRO User s Manual 135 Sibelmed DATOSPIR MICRO SIBEL S A ROSSELLO 500 08026 BARCELONA PULMONARY FUNCTION TEST DATOSPIR MICRO Code 0000000001 Date 03 22 2006 Time 17 52 Name Sex Male s 26 Height cm 174 Wt Kg 68 Temp 26 Pres mmHg 760 Eier 60 Smok I 0 References SEPAR Ethnic 100 Reason Origin Te ician Bios Ver 5115 1 00 Prog Ver 5115AF 1 00 MVV REPORT MANOEUVRE No 1 1 OBS REF MVV 1 150 82 179 00 84 Br min 44 12 511 A00 MU2 REV 2 03 1931deu5 uonejodo 2 pue sjapow Chapter 3 Models B C Operation PLA DATOSPIR MICRO User s Manual 136 3 7 POST BRONCHIAL DILATOR SPIROMETRY PROCEDURE The DATOSPIR MICRO spirometer allows for Post bronchial dilation tests to be carried out in FVC VC and MVV provided a test has previously been completed in PRE bronchial dilator mode and saved on the database The purpose of this operating mode is to provide PRE and POST spirometric results of applying a bronchial dilating drug in the same report The procedure to carry out Post bronchial dilating Spirometry is as follows 1 Complete FVC VC or MVV test the patient before applying the dilating drug as described in the previous sections 2 Memorise the PRE test in the database to compare it in POST mode as explained in MEMORISING FVC TESTS in section 3 4 3 Apply the dosage
48. 3 S be med DATOSPIR MICRO User s Manual 217 individuals is more complicated and less accessible this procedure cannot be performed more often than every month or whenever the appliance is thought to be malfunctioning Table I Variability of spirometry in healthy patients Variation coefficient Variables Age 6 20 20 70 FVC 1 9 2 2 FEV1 2 2 2 2 25 75 6 5 4 8 FEF50 9oFVC 5 3 4 7 Values corresponding to 33 healthy volunteers Values from 20 healthy adults According to ATS ERS standardisation parameters MEF50 is replaced by FEF50 7 3 VALUES OF REFERENCE FOR FORCED SPIROMETRY SEPAR The DATOSPIR MICRO spirometer includes different tables of reference that may be selected using the Customisation programme Below are the equations corresponding to the SEPAR and ECCS 93 references Should you require any other table please consult SIBEL S A 511 A00 MU2 REV 2 03 Asyowosids 193deu 5 Chapter 7 Spirometry Technique Sibelmed DATOSPIR MICRO User s Manual 218 Multi centre study in Barcelona Variable Sex Equation Age 6 20 R SEE FVC 0 028007 0 03451 0 05728 3 21 0 947 0 443 0 030497 0 02220 0 03550 3 04 0 935 0 313 FEV1 0 02483 0 02266 0 07148 2 91 0 945 0 378 0 028667 0 01713 0 02955 2 87 0 940 0 263 FEV1 FVC 0 593E 0 113P 81 60 0 026 82 60 FEF 25 75 0 038 0 140E 4 33 0 832 0 796 0 046 0
49. 436 00 07 e mail export sibelmed com Technical service Tel 34 93 433 54 50 e mail sat sibelmed com Fax 34 93 436 16 11 Website www sibelmed com SIBEL S A belongs to SIBELGROUP r Sibel sss Sibelmed DATOSPIR MICRO User s Manual 3 INDEX DECLARATION OF 7 9 1 INSTRUCTIONS FOR USE AND INSTALLATION 17 1 1 18 1 2 PRELIMINARY 5 65 19 1 3 DATOSPIR MICRO SPIROMETER MODELS 20 1 4 LAYOUT OF CONTROLS PILOT LIGHTS AND 5 24 1 5 INSTALLATION AND 5 26 1 6 OPERATING 5 30 2 MODEL OPERATION 33 2 1 FUNCTION 34 2 2 EQUIPMENT 5 5 38 2 3 EQUIPMENT PROTECTION 42 2 4 FORCED VITAL CAPACITY FVC TEST PROCEDURE 43 2 5 SLOW VITAL CAPACITY VC TEST PROCEDURE 63 2 6 MAXIMUM VOLUNTARY VENTILATION
50. 511 A00 MU2 REV 2 03 Sibelmed 7 DATOSPIR MICRO User s Manual 107 Mode of comparison between PRE bronchial D and POST bronchial W Average weighted 9o between PRE and POST 9o between REF and POST 9o Percentage between PRE and POST Dif Difference between PRE and POST Warnings Printout of warnings of Non Compliant manoeuvres with ATS ERS criteria Date of latest calibration CUSTOMISATION OF THE HOME MODE In this option it is possible to configure the DATOSPIR MICRO for use in home mode See section 3 13 HOME MODE OPERATION STANDARD CONFIGURATION This option memorises a user defined customisation programme status to retrieve it at any time globally and automatically This option restores the original customisation if it has been modified either voluntarily or inadvertently In general this configuration will correspond to that most often used CONFIG STANDARD 16 07 511 A00 MU2 REV 2 03 2 pue g sjapow 1oe3deu Chapter 3 Models C Operation sibelmed DATOSPIR MICRO User s Manual 108 Restores the standard configuration Saves the standard configuration Follow the instructions below to save the Standard configuration 1 Customise each of the following options Home mode customisation Database customisation Common customisation Spirometry customisation Pulse oximetry customisation Protection customisation as described in this section
51. 60601 1 2006 AC 2010 Seg medical equipment Class IP Internally powered Continuous use 511 A00 MU2 REV 2 03 suoneoyi2eds e2iuu22 6 193deu Chapter 5 Technical Specifications Sibelmed 7 DATOSPIR MICRO User s Manual 202 e EN 60601 1 2 2007 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 spirometry No SEPAR recommendations 1 Arch Bronconeumol 1989 25 132 142 PULSE OXIMETRY e EN ISO 9919 2009 General requirements for basic safety and essential performance for medical pulse oximetry USABILITY AND APTITUDE FOR USE EN 60601 1 6 2010 General requirements for safety Part 1 6 Collateral standard Usability 511 A00 MU2 REV 2 03 Sibelmed 7 DATOSPIR MICRO U
52. 8 PULSE OXIMETRY TEST PROCEDURE Occasional Oxygen Saturation SpO and Pulse Rate PR tests or long term studies particularly aimed at controlling patients during sleep or in any other situation desaturation measurement etc can be performed During long term studies it is wise to secure the sensor to the patient s finger using a plaster as shown the following figure The plaster must not place too much pressure on the finger so as not to modify perfusion in the finger PULSE OXIMETRY CUSTOMISATION The SpO module is an option included in the DATOSPIR MICRO Each user should customise it to suit their needs To access the pulse oximetry customisation menu start the DATOSPIR MICRO using the key i Press and S 511 00 02 2 03 Sibelmed 7 DATOSPIR MICRO User s Manual 141 83 686 5 02 CUST Exits this screen and goes back to the previous one Average SpO configuration and beeping sound Parameter configuration Trends graph Press and the following screen will appear Average SP Z Beer You can e Configure the average SpO e Enablethe beeping sound signal coinciding with each pulse SI pue g 2 Sibelmed DATOSPIR MICRO User s Manual 142 Press and the following screen will appear 02 Tor Bot Ref 188 Tor 100 Sereen Time mimes
53. 96 d lel rT FEW 104 REF 5 45 4 38 or Makes the graph larger or smaller e Pressing on the reference area top part of the screen accesses the patient s details The technician who is going to carry out the forced spirometry tests must know the normal procedures required so that the patient can be coached Otherwise it is recommended to review documentation on the matter 511 A00 MU2 REV 2 03 J pue sjapow 1oe3deu Chapter 3 Models B C Operation 6 DATOSPIR MICRO User s Manual 118 When undertaking spirometry take the following steps into account 1 Check that the turbine is correctly inserted with the mouthpiece as in the figure INSERT FIRMLY 2 Instruct the patient as to how to the test is being carried out as his cooperation is vital for it to be completed correctly Review Chapter 7 SPIROMETRY TECHNIQUE Patients can carry out the spirometry manoeuvres in two different ways e The first consists in starting the manoeuvre with FORCED EXPIRATION followed by FORCED INSPIRATION if required e In the second way the patient breaths normally through the turbine and when indicated by the technician takes a deep breath filling completely his lungs and then performs a FORCED EXPIRATION followed by FORCED INSPIRATION if required Inform the patient of how to hold the equipment when using the spirometer taking care not to press any ke
54. ASE OF ANY PART IS MISSING OR IS DAMAGED NOTIFY US AS QUICKLY AS YOU CAN IF YOU DETECT ANY DAMAGE IN THE PACKAGING CONTACT WITH YOUR DISTRIBUTOR BEFORE PROCEEDING TO INSTALL IT DO NOT THROW AWAY THE PACKAGING BAGS ETC UNTIL THE CORRECT FUNCTIONING OF THE DEVICE IS VERIFIED IN THE CASE OF RETURNING THE GOODS IT WILL BE APPRECIATED THAT YOU SEND THE DEVICE IN PERFECT ORDER WITH ALL THE ACCESSORIES AND PROPERLY PACKAGED ANY DAMAGE SUFFERED WILL MAKE A CHARGE CORRESPONDING TO REPAIR OR NEW PARTS PREPARADO PREPARED Fecha Date 511 00 02 REV 2 03 Sibelmed DATOSPIR MICRO User s Manual 23 WARNING According to the different regulations particularly the 93 42 EEC Medical Device Directive electromedical devices should be verified and or calibrated regularly to ensure reliable functions and the safety of patients users and the environment As well as the routine DATOSPIR MICRO spirometer calibrations its safety systems adjustments and functions etc should undergo a general annual service and under no circumstances exceed an eighteen month period without having been serviced These checks should also be made whenever the equipment is thought to be working incorrectly These checks must be carried out by the manufacturer or by skilled technical personnel authorised by SIBEL S A according to the manufacturer s SIBEL S A Verification and Adjustment Procedures All acce
55. C simply install the USB driver and the W20 Spirometry Software in the PC For both installations consult the W20 Spirometry Software User Manual 511 A00 MU2 REV 2 03 pue esr 10J 2 15 T Chapter 1 Instructions for Use and Installation Sibelmed DATOSPIR MICRO User s Manual 28 BLUETOOTH MODULE INSTALLATION This case is similar to the above By inserting the optional Bluetooth module the equipment is ready to transmit data via Bluetooth For use with a PC simply install the Bluetooth module and the W20 Spirometry Software in the PC The PC is then ready to receive the data transmitted by the equipment For both installations consult the W20 Spirometry Software User Manual Once the Bluetooth module has been configured in the PC a connection will be established every time the equipment and the PC are started Although the DATOSPIR MICRO internal Bluetooth module uses batteries particularly during data transmission it is wise to disable the module if no connection with the PC is required This will extend the working life of the batteries The Bluetooth is enabled and disabled by accessing the Bluetooth option on the main screen EQUIPMENT PROTECTION In compliance with the Data Protection Act LOPD the DATOSPIR MICRO has an equipment protection option accessed by PIN accessed by a pin of 4 digits This option can be customised enabled or disabled as requ
56. CAPACITY VC TEST PROCEDURE The procedure to carry out the slow Vital Capacity VC test is similar to that described in section 3 4 FORCED VITAL CAPACITY FVC PROCEDURE with the following variations 1 Access the VC test by pressing the key from the main screen and perform a manoeuvre EF 1 17 28 02 05 i EF 1 17 26 030E bw PP we TY EME 5 17 1 23 5 17 1 23 i mz 14 85 8 58 T D 2 14 85 8 58 14 54 1 09 14 51 1 09 M4 13 88 1 73 5 13 88 1 72 2 axes always displayed VOLUME TIME mode 3 Instruct the patient as to how to the test is being carried out as his cooperation is vital for it to be completed correctly 4 The maximum time allowed for the manoeuvre is 45 seconds The equipment saves a maximum of five manoeuvres ordered according to the VC value where M1 is the best VC and M5 the worst 5 measure the ERV and TV parameters correctly each manoeuvre must have at least four respiratory cycles 511 A00 MU2 REV 2 03 Sibelmed 7 DATOSPIR MICRO User s Manual 133 6 The registering of parameters and graphs is as shown below Sibelmed DATOSPIR MICRO SIBEL S A ROSSELLO 500 08026 BARCELONA PULMONARY FUNCTION TEST DATOSPIR MICRO 41931deu5 uonejodo 2 pue sjapow 0000000001 Date 03 22 2006 Time 17 52 1 Men 26 Height cm 174 Wt Kg 68
57. DATOSPIR MICRO SPIROMETER USER MANUAL 5 511 00 02 REV 2 03 2014 06 Sibelmed 6 DATOSPIR MICRO User s Manual 2 SIBEL GROUP is a group of Spanish manufacturers made up of SIBEL S A SIBELMED MEDITEL INGENIERIA MEDICA BITMED and APARATOS Y SISTEMAS DE MEDIDA S A ASIMED The above mentioned group comprises companies that without losing their own identity collaborate closely to manufacture and commercialise their products with one sole aim that is to offer their respective clients a wider range of quality products manufactured in Spain as well as an improved service As you are aware SIBEL S A designs and manufactures medical equipment under the trademark SIBELMED mainly in the following areas RESPIRATORY OTOLARYNGOLOGY AND SLEEP PATHOLOGY The company MEDITEL INGENIERIA MEDICA S L designs and manufactures products for electromedicine and sport under the trademark BITMED Its main business areas are ELECTROENCEPHALOGRAPHS POLYGRAPHS POLYSOMNOGRAPHS AND PORTABLE SYSTEMS FOR THE STUDY OF FOOT SUPPORT The company APARATOS Y SISTEMAS DE MEDIDA 5 designs and manufactures measuring products under the trademark ASIMED such as ELECTRONIC AND MECHANICAL PERSON AND BABY WEIGHING SCALES FLOOR BED CHAIR AND DIET SCALES SIBEL S A Rossell 500 08026 Barcelona Spain National Sales Tel 93 436 00 08 e mail comercial sibelmed com International Sales Tel 34 93
58. E and POST between REF and POST between PRE and POST Difference between PRE and POST Printout of warnings of Non Compliant manoeuvres with ATS ERS criteria e SpO Pulse oximetry customisation 511 00 02 REV 2 03 Sibelmed 7 DATOSPIR MICRO User s Manual 103 e Equipment protection customisation Modifying the pin MAINTENANCE e Warning selection Period between calibrations Period between maintenance work Adjusting the LCD contrast TouchPannel calibration Checking hardware Checking with standard curves FVC VC MVV Others Notifies Programme Update key and allows System initialisation OPERATING MODE e Home e Hospital PULSE OXIMETRY e Test data Patient Code Full name Age height weight and sex e Configuration Average in the SpO e Saving Trends e Displaying Trends Configuration Signal forwards and backwards Test Parameters Parameter printout Saving parameters on the database 511 A00 MU2 REV 2 03 uonesdo J pue g sjapow 1oe3deu Chapter 3 Models B Operation sibelmed DATOSPIR MICRO User s Manual 104 DILATION e Carrying out Post bronchial dilation test REPORT e Printing a report BLUETOOTH e Enabling or disabling Bluetooth 511 A00 MU2 REV 2 03 Sibelmed 7 DATOSPIR MICRO User s Manual 105 3 2 EQUIPMENT CUSTOMISATION Every user should customise the DATOSPIR MICRO spirometer according to their requirements due to the variety of options included
59. IENT DETAILS Code xxxxxxxxxx Between 0 and 9999999999 PATIENT DETAILS Age years xx Between 4 and 100 PATIENT DETAILS Height cm xx Between 50 and 230 cm PATIENT DETAILS Weight Kg xx Between 15 and 200 Kg 511 A00 MU2 REV 2 03 Sibelmed 7 DATOSPIR MICRO User s Manual PATIENT DETAILS Sex Female Between male and female PATIENT DETAILS Cig day xx Between 0 and 20 cigarettes Select HOME MODE 2 Test data to configure the semaphore and the alarms The following screen will appear SEL SEMAPHORE FVC FEV1 PEF Select the parameter of reference for the manoeuvres The value of REFERENCE will then appear depending on the age height etc of the patient and the tables enabled in the Customisation programme This value can be changed by the specialist for patients who under controlled conditions of asthma have a significant deviation regarding the standard of the reference The value programmed will be equivalent to 100 in the subsequent control VALOR REFERENCIA FVC XX XX Select the value where necessary and press gt i 511 A00 MU2 REV 2 03 y 4 Chapter 2 Model A Operating Sibelmed 7 DATOSPIR MICRO User s Manual 94 The levels must be defined in percentages in relation to the value previously selected from among the different semaphore indicators The standard levels are GREEN Zone Between 100 and 80 Normal YELLOW Zone Betw
60. LINK 1 MANUAL DE USO CASTELLANO Doc 511 A00 MU1 ENGLISH USER MANUAL Doc 511 A00 MU2 03037 1 SOFTWARE ESPIROMETR A W 20 DEMO Compuesto por SPIROMETRY SOFTWARE W 20 Composed by e SOFTWARE W 20 CD 511 8FA 02305 1 LICENCIA SOFTWARE ESPIROMETR A W 20 SPIROMETRY LICENSE SOFTWARE W 20 03031 1 OPCI N PULSIOXIMETRIA SOFTWARE W 20 PULSEOXIMETRY W 20 SOFTWARE OPTION 03028 1 OPCI N BRONCOCONSTRICCI N SOFTWARE W 20 BRONCHOCONSTRICTION W 20 SOFTWARE OPTION 02562 OPCION IMPRESORA EXTERNA USB USB EXTERNAL PRINTER OPTION 01682 1 CABLE MINI USB 5 PINES USB B gt 511 A00 MU2 REV 2 03 T 193deu5 5 pue esr 40 2 1 UOI Instructions for Use and Installation Chapter 1 Sibelmed 7 DATOSPIR MICRO User s Manual RELACION DE CONTENIDO PACKING LIST Pagina 2 de 2 DATOSPIR MICRO 511 08 010 REV 9 2013 06 MODELOS MODELS CODIGO CANT DESCRIPCION CODE QTY DESCRIPTION 01005 MODULO PULSIOXIMETRIA SENSOR FLEXIBLE Compuesto por FLEX PULSEOXIMETRY MODULE Composed by 07021 1 e MODULO PULSIOXIMETRIA XPOD i XPOD PULSEOXIMETRY MODULE 1 e SENSOR PULSIOXIMETRIA FLEXIBLE SPO 07000 FLEX PULSE OXIMETRY SPO2 SENSOR sat 02639 1 e SENSOR PULSIOXIMETRIA 25 ed PULSIOXYMETRY PROBE ADHESIVE 25 u mE MODULO PULSIOXIMETRIA SENSOR PINZA Compuesto por PULSEOXIMETRY MODULE ARTICULATED SENSO
61. R Composed by 07021 1 e MODULO PULSIOXIMETRIA XPOD XPOD PULSEOXIMETRY MODULE 00709 1 e SENSOR PULSIOXIMETRIA PINZA SPO ARTICULATED PULSE OXIMETRY 5 SENSOR 02474 1 MODULO BLUETOOTH BLUETOOTH MODULE 01145 1 ADAPTADOR BLUETOOTH BLUETOOTH ADAPTER 04195 1 INSTRUCCIONES ADAPTADOR ADAPTER INSTRUCTIONS 02560 1 OPCI N FIRMWARE DIAGNOSTICO DIAGNOSTIC FIRMWARE OPTION 06994 1 OPCI N FIRMWARE BASE DATOS 1000 PRUEBAS 1000 TEST DATA BASE FIRMWARE OPTION 01739 1 CARGADOR 4 PILAS CHARGER 4 BATTERY STANDARD OPCIONAL OPTIONAL NO DISPONIBLE NOT AVAILABLE NOTA LOS ART CULOS Y CANTIDADES RELACIONADAS ANTERIORMENTE HAN SIDO CUIDADOSAMENTE COMPROBADAS EN CASO DE FALTAS O DESPERFECTOS PROCEDAN A COMUNIC RNOSLO LO MAS PRONTO POSIBLE SI DETECTA ALG N DETERIORO EN EL EMBALAJE CONTACTE INMEDIATAMENTE CON LA AGENCIA DE TRANSPORTE Y CON 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 S RVANSE DEVOLVERNOS UNA COPIA DEL ALBARAN SELLADA Y FIRMADA EN CASO DE DEVOLUCI N DE MATERIAL O EQUIPO EN DEPOSITO ROGAMOS NOS LO ENV EN EN PERFECTO ESTADO COMPLETO DE ACCESORIOS Y DEBIDAMENTE EMBALADO CUALQUIER DESPERFECTO OCASIONADO PROVOCAR A UN CARGO CORRESPONDIENTE A LA REPARACI N O REPOSICI N NOTE THE ITEMS AND QUANTITIES RELATED BEFORE HAVE BEEN CAREFULLY CHECKED IN C
62. RATING MODE Home mode Hospital mode BLUETOOTH 511 A00 MU2 REV 2 03 y 4 Chapter 2 Model A Operating Sibelmed 7 DATOSPIR MICRO User s Manual 38 2 2 EQUIPMENT CUSTOMISATION Every user should customise the DATOSPIR MICRO spirometer according to his requirements due to the multiple variety of options included The different options included in the Customisation menu are explained in detail in the previous section SPIROMETRY CUSTOMISATION This option customises any suboptions specific to the spirometric tests 1 References The type of reference required can be selected SEPAR ERS KNUDSON CRAPO ZAPLETAL MORRIS AUSTRIA GUTIERREZ CHILI CASTRO BRAZIL POLGAR WENG P PADILLA MEXICO HANKINSON A J CRUZ MEXICO GOLSHAN IRAN for adults and children and the ethnic factor It prioritises the age range selected for adults if a different table is chosen for children It extrapolates the values for the ages outside the table range selected 2 Parameters The observed or measured parameters to be used can be selected This is only at display level or for the report All the parameters are saved to the database and can be enabled at any time 3 Graphics The graphics can be saved to the database 4 Diagnosis The type of diagnosis can be selected Miller or Snider Kory amp Lyons 511 A00 MU2 REV 2 03 Sibelmed 7 DATOSPIR MICRO User s Manua
63. REV 2 03 5 Appendix 3 Modifications Sibelmed DATOSPIR MICRO User s Manual 238 511 A00 MU2 REV 2 03
64. ROSSELLO 500 08026 BARCELONA PRUEBA DE FUNCION PULMONAR DATOSPIR MICRO C digo 0000000001 Fecha 20 10 2005 Hora 18 36 Nombre f Sexo Hombre Edad 27 Talla 174 Peso Kg 68 Temp C 26 Pres mmHg 760 Humedad 60 I Fuma 0 Referencias SEPAR F Etnico 100 Motivo Procedencia T cnico Ver Bios 511A5B 1 00 Ver Prog 511A5F 1 00 INFORME DE VC MANIOBRA N 1 2 PARAMETRO OBS REF 5 1 36 TV l TD ERV x 0 72 Comentarios 3320990909 sian 511 A00 MU2 REV 2 03 Sibelmed 7 DATOSPIR MICRO User s Manual 2 6 MAXIMUM VOLUNTARY VENTILATION MVV TEST PROCEDURE The procedure to carry out the Maximum Voluntary Ventilation test is similar to that described in Section 2 4 FORCED VITAL CAPACITY FVC PROCEDURE with the following variations 1 Ifthe test is carried out on the same patient as described in the OTHER TESTS ON THE SAME PATIENT section go back using the lt key to the Test Selection window and select using keys or the test SPIROMETRY 3 MVV If the patient is new begin as described in the ENTERING PATIENT PARAMETERS section 2 Instruct the patient as to how to carry out this type of test as his cooperation is vital for it to be completed correctly The maximum time allowed for the manoeuvre is 15 seconds The equipment saves a maximum of three manoeuvres ordered according to the MVV value where M1 is the best MV
65. SIMBOLOGY 54555 E ERR 205 OPERATING PRINCIPLES 207 TURBINE 208 TURBINE ROTATION 5 5 208 SER RR pA 209 PULSE 211 SPIROMETRY TECHNIQUE 213 511 A00 MU2 REV 2 03 Index Sibelmed DATOSPIR MICRO User s Manual 6 7 1 PROCEDURE 222 214 7 2 CALIBRATIONS 215 7 3 VALUES REFERENCE FOR FORCED SPIROMETRY SEPAR 217 7 4 VALUES OF REFERENCE FOR FORCED SPIROMETRY 5 A 219 7 5 OTHER VALUES OF REFERENCE 220 8 UPKEEP PREVENTATIVE AND CORRECTIVE MAINTENANCE 221 8 1 UPKEEP 222 8 2 PREVENTATIVE 224 8 3 CORRECTIVE 225 APPENDIX 1 ELECTROMAGNETIC COMPATIBILITY 227 APPENDIX 2 COMPLIANCE WITH THE DATA PROTECTION ACT 5 233 APPENDIX 65 237 511 A00 MU2 REV 2 03 Sibelmed DATOSPIR MICRO
66. ST FUNCTIONS AND PARAMETERS FORCED VITAL CAPACITY FVC Parameters FVC FEV 5 FEV1 FEV3 FEV 5 FVC FEV1 FVC FEV3 FVC FEV1 VC PEF FEF759 FEF509 0 FEF759 FEF25 75 FEF75 85 FET25 75 FET100 1 Forced Vital Capacity 1 Forced Expirometry Volume in 0 5 seconds 1 Same in 1 second 1 Same 3 seconds 9o Ratio 9o Ratio 9o Ratio 9o Ratio 1 6 Flow Apex 1 5 Maximum Expiratory Flow with 75 of FVC remaining in the lungs 1 5 Same with 50 of FVC 1 5 Same with 25 of FVC l s Forced mesoexpiratory flow 1 5 Average flow between 75 85 of FVC s Time passed between 25 75 of FVC s Forced Expiratory Time FEF50 FIF50 Ratio FEV1 FEV 5 FEV1 PEF Ratio Ratio 511 00 02 REV 2 03 Sibelmed 7 DATOSPIR MICRO User s Manual 193 e FIF50 1 5 Maximum Inspiratory flow with 50 of FVC inspired e FIVC 1 Forced Vital Inspiratory Capacity e FIV1 1 Forced Inspirometry Volume in 1 second e FIV1 FIVC 9o Ratio e FEV1 FIV1 9o Ratio e PIF 1 5 Inspiratory Flow Apex e s Mean Transit Time e PEF PIF Ratio e Vext 9o Volume extrapolated in relation to FVC e MVVInd l min Maximum indirector Voluntary Ventilation 30 x FEV1 e FEV6 1 Forced Expirometry Volume in 6 seconds e FEV1 FEV6 Ratio e EPOC rate Parameter that depends on the number of cigarettes smoked a day the age and FEV1 Indicates t
67. See section 3 8 PULSE OXIMETRY TEST PROCEDURE EQUIPMENT PROTECTION CUSTOMISATION This allows you to change the PIN required to start the equipment if the protection option is enabled and to enable or disable equipment protection The pin code must be of 4 digits The following screen appears on accessing this option CHANGE Current Pind Pin Enabled O Mew Pin New Pin CO To enable the protection tick the Pin Enabled checkbox and enter the PIN in the New Pin boxes To change the PIN you must enter the current one in the Current Pin box If an erroneous PIN is entered three times the equipment will lock and switch off The PIN can be disabled again by entering the current PIN and unticking the Pin Enabled checkbox Sibelmed 7 DATOSPIR MICRO User s Manual 111 DATABASE CUSTOMISATION This option allows you to choose the number of registers to be advanced if performing a fast advance using the database search engine EXPLORER FAST of Registers 18 511 00 02 e REV 2 03 2 pue g sjapow 1oe3deu Sibelmed DATOSPIR MICRO User s Manual 112 3 3 EQUIPMENT PROTECTION If equipment protection has been enabled the following screen will appear when it is started ENTER Enter the PIN and press If the PIN configured in Equipment protection customisation is entered access will be given to the DATOSPIR MICRO a
68. Select the option and following the instructions on the screen which are similar to the FVC VC and MVV procedures With these curves you can operate the equipment as if they were real patient curves with slight exceptions 511 A00 MU2 REV 2 03 S be med 7 DATOSPIR MICRO User s Manual 87 2 11 UPDATING INTERNAL SOFTWARE The DATOSPIR MICRO spirometer has two types of internal software e Bios basic hardware control programme e Flash programme containing all the equipment options The update option allows for the version of Bios and or Flash to be updated without having to take the equipment to the factory and without having to open it WARNING Both updates are completed through the series port RS232 BIOS UPDATE The updating process for the BIOS programme is as follows 1 Run the W 20 Spirometry Software and access the Configuration Hardware Test option Run a communications test to check that the connections are correct 2 Switch the equipment off With the DATOSPIR MICRO switched off remove the rear cover disconnect the bluetooth where applicable and turn both switches ON 511 A00 MU2 REV 2 03 y 4 Chapter 2 Model Operating Sibelmed 7 DATOSPIR MICRO User s Manual 88 WARNING This option should be carried out by an expert or specialist 4 Turn the equipment and support it on the table with the screen visible 5 Press the key
69. T 136 3 8 PULSE OXIMETRY TEST PROCEDURE 140 3 9 CALIBRATION 151 3 10 INTERNAL 4 157 3 11 MAINTENANCE PROGRAMME 164 3 12 UPDATING INTERNAL 5 170 3 13 HOME MODE 174 511 A00 MU2 REV 2 03 6 DATOSPIR MICRO User s Manual 5 4 1 4 2 4 3 4 4 5 1 5 2 5 3 5 4 5 5 5 6 6 1 6 2 6 3 6 4 COMMUNICATIONS SYSTEM 185 TRANSFERRING EQUIPMENT CHEQUE DATA AND 4 2 4 Va 186 PATIENT TEST MANAGEMENT IN THE PC 188 EXPORTING TESTS TO OTHER SYSTEMS 189 SPIROMETRY SOFTWARE W 20 FOR 190 TECHNICAL SPECIFICATIONS 191 TYPES OF TEST FUNCTIONS AND PARAMETERS 192 MEASURING 5 8 4 197 MICRO lt 199 PRESENTATION 200 TEMPERATURE 6 5 200 GENERAL DATA E rau E Y 200 5 6 1
70. TEST ed DATOS PIR MTCR O nomanbpnami Date 4 Def 2 006 Time 11 34 lame Sex Male age z 27 em 174 WL Hy 68 C a6 Dres 750 Humidity 60 Smok T 0 Refsrences SLPAR 100 Heuson Origin lan Ver 00 Prog Vor 4115F 1 00 EVC REDORT MARORIVRR 1 7 PARAMETER FEF ij Rast di Ne 5 35 114 Geel FEVL L 1 1 27 10 TUC ft 5 99 12 PRYL 1 4 26 4 27 109 EEWVL FWVC id 17 44 Bb 6 50 19 11 44 UE 4 78 PERUSE Yb 17 3 42 1 50 FEVD N 1 57 1 425 4 10 53 Bad 165 be dee ea ei d 15 n b 3 4 n 15 g 511 00 02 REV 2 03 2 pue sjapow sibelmed DATOSPIR MICRO User s Manual 130 DELETING A MANOEUVRE MADE The DATOSPIR MICRO spirometer deletes any manoeuvre made whether it is because you are doubtful as to whether its values are correct due to a defective performance which may distort the results or for any other reason The manoeuvre selected by default is the best M1 If you want to delete another it must first be selected Select the manoeuvre to be deleted flashing from the test screen and press The following messag
71. U2 REV 2 03 pue esf 40J suomonajsug 4o3deu 5 Chapter 1 Instructions for Use and Installation Sibelmed DATOSPIR MICRO User s Manual 1 5 INSTALLATION AND START UP DATOSPIR MICRO INSTALLATION The DATOSPIR MICRO spirometer is CLASS IIa according to the criteria of the 93 42 EEC European Medical Device Directive and in line with the type of protection against electric shocks established by the EN60601 1 standard the equipment is rated as CLASS IP type B Batteries The DATOSPIR MICRO spirometer works as standard using two AA 1 5 V batteries or optionally using rechargeable NiMh batteries AA 1 2 V type If you are not going to use the device for a while remove the battery to avoid they could spill its substances WARNING Never try to recharge alkaline batteries This would cause damage to both the batteries and the charger In both cases the autonomy will depend on the quality of the batteries used In Model A 1 5 V alkaline batteries or with 2400 mAh rechargeable batteries will last for approximately 40 hours Autonomy may drop by 50 when working via Bluetooth and USB connection to the PC will not use any batteries given that the equipment is powered through the PC s USB port In models B and C battery life will be smaller than model A It will be directly affected by time that Lcd Backlight is on The charging time for rechargeable NiMh batteries will depend on the charger used
72. User s Manual 7 The DATOSPIR MICRO Spirometer has been designed by the SIBEL S A R amp D amp i Department with the cooperation of the Hospital de la Santa Creu y Sant Pau Pulmonary Function Laboratory in Barcelona in line with the standardisation criteria of International Institutions ATS ERS TASK FORCE American Thoracic Society European Respiratory Society and National Institutions SEPAR Spanish Neumology and Thoracic Surgery Society PRODUCT CONFORMS WITH 93 42 CEE Medical Devices Directive Class IIa Revised Approved Date 2014 06 Date 2014 06 4 FA Antoni Pic Carlos Recio Technical Director Sales Director 511 A00 MU2 e REV 2 03 A31uL10JUO JO Declaration of Conformity Sibelmed 7 DATOSPIR MICRO User s Manual 8 511 A00 MU2 REV 2 03 S belmed 7 DATOSPIR MICRO User s Manual 9 SAFETY SPECIAL PRECAUTIONS The DATOSPIR MICRO spirometer has been designed for use with the utmost safety All operating instructions must be read before using the DATOSPIR MICRO Not doing so may lead to injuries to the user or the patient and damage to equipment and or accessories INTENDED USE The spirometer measures and calculates a series of parameters related to the human respiratory function The spirometer is not designed for use outdoors or under other conditions or using other power sources not indicated in this manual The spirometer is not intended to be used in transport vehicles
73. V 2 03 y 4 Chapter 2 Model A Operating S belmed DATOSPIR MICRO User s Manual 50 FVC X XX YY FEV1 yy X XX Observed Value of the parameter in this case FVC YY between the Observed value and the value of Reference X XX Observed Value of the parameter in this case FEV1 yy 9o between the Observed value and the value of Reference ATTENTION Check in the Customisation Programme that the REFERENCES and the ETHNIC FACTOR are suitably selected The ethnic factor modifies the value of the References according to the percentage selected 100 is equivalent to the unmodified standard value of the References Using the selection keys or v it is possible to view the observed value and the percentage in relation to the value of reference for each customised parameter If a parameter does not have a Value of Reference the corresponding percentage will not appear 6 Press the gt key again complete new manoeuvre As many manoeuvres as required can be completed The DATOSPIR MICRO will always save the five best for FVC and VC and the three best for MVV according to ATS ERS criteria No more than eight manoeuvres should be made so as not to tire the patient 511 A00 MU2 REV 2 03 Sibelmed 7 DATOSPIR MICRO User s Manual 51 If three or more manoeuvres have been completed and the FVC and or FEV1 parameters are flashing this indicates th
74. V and M5 the worst 4 The register of parameters and graphics is as shown below 511 A00 MU2 REV 2 03 y 4 Model A Operating Chapter 2 Sibelmed DATOSPIR MICRO User s Manual Sibelmed DATOSPIR MICRO SIBEL S A ROSSELLO 500 08026 BARCELONA PRUEBA DE FUNCION PULMONAR DATOSPIR MICRO C digo 0000000001 Fecha 20 10 2005 Hora 18 36 Nombre Hombre Edad 27 Talla cm 174 Peso Kg 68 Temp C 26 Pres mmHg 760 Humedad 60 I Fuma 0 Referencias SEPAR F Etnico 100 Motivo Procedencia T cnico Ver Bios 511A5B 1 00 Ver Prog 511A5F 1 00 INFORME DE MVV MANIOBRA N 1 2 PARAMETRO OBS REF 3 MVV i 1 min 150 82 177 74 85 Br min 44 12 Comentardog T CRI S E E 511 A00 MU2 REV 2 03 Sibelmed 7 DATOSPIR MICRO User s Manual 2 7 PROCEDIMIENTO DE LA ESPIROMETRIA 2 7 POST BRONCHIAL DILATOR SPIROMETRY PROCEDURE The DATOSPIR MICRO spirometer allows for Post bronchial dilation tests to be carried out in FVC VC and MVV provided a test has previously be completed in PRE bronchial dilator mode and saved to the database The purpose of this operating mode is to provide PRE and POST spirometric results of applying a bronchial dilating drug in the same report The procedure to carry out Post bronchial dilating Spirometry is as follows 1 Complete FVC VC or MVV test on the patient before applying the
75. anual 82 LCD CONTRAST Select the option MAINTENANCE 2 LCD contrast Using keys and v this option enables you to configure the screen contrast EQUIPMENT CHECK Select the option MAINTENANCE 3 Equip Check This option allows for different parts of the equipment to be checked Using keys select EQUIPMENT CHECK 1 Ext Printer to check the external printer selected The SIBELMED logo will be printed along with the heading lines and 10 lines of characters EQUIPMENT CHECK 2 ADCs 511 A00 MU2 REV 2 03 Sibelmed 7 DATOSPIR MICRO User s Manual to see the values of the following variables No Pulses 0150 Turbine Fact 200 B OK 4V OK LiB OK 26 C EQUIPMENT CHECK 3 LCD to test the LCD using a Bar test a bar is drawn alternately on the top and bottom line of the LCD Contrast scan EQUIPMENT CHECK 4 CPU to check the CPU 1 Calculates the flash checksum The top line indicates the current direction and the bottom line the checksum 0x300000 Chk Flash 0x59D9 511 00 02 REV 2 03 y 4 Chapter 2 Model A Operating S belmed DATOSPIR MICRO User s Manual 84 2 Calculates the bios checksum 0x20000 Chk Bios 0xBA47 Tests the internal RAM successively writing and reading the value 0x55 in the internal RAM The top line indicates the current direction and the bottom line the numb
76. at the repeatability criterion for one or both parameters has been met This criterion indicates that the best two observed values of FVC and the best two of FEV1 differ in no more than 150 ml if the FVC is greater than 1 litre or in no more than 100 ml if the FVC is below or equal to one litre NOTE Remember that the back key takes you back in the menu without losing the information available to date except where you change patient ATS ERS criteria The manoeuvre with least warnings is considered the best ET EX With the same number of warnings the manoeuvre with the highest value sum of FVC FEV1 is considered the best DISPLAYING RESULTS The results can be seen once at least one manoeuvre has been completed To do so go back to the following screen FVC TEST 1 Start Manoeuv and using the keys select the option FVC TEST 2 Results 511 A00 MU2 REV 2 03 y epow 4 Chapter 2 Model Operating S belmed DATOSPIR MICRO User s Manual 52 Press the gt key similar screen to the following will appear RESULTS 1 2 M3 4 M5 Indicates the number of manoeuvres in the memory The best M1 will always be selected flashing text by default This screen indicates the following e Number of manoeuvres on memory There may be from one to five manoeuvres e manoeuvres are ordered according to ATS ERS criteria explained in
77. base has been selected on the test screen press the key The following screen will appear f Press the key The following message will appear indicating that the manoeuvre has been saved Chapter 3 Models C Operation Sibelmed DATOSPIR MICRO User s Manual 128 The DATOSPIR MICRO spirometer print any manoeuvre made using an external printer The manoeuvre selected by default is the best M1 If you want to produce a report on another it must first be selected Check that the printer is ready and connected Select the manoeuvre to be printed flashing from the test screen and press The best M1 is recommended The following screen will then appear to indicate the printing process REPORT 4 The printer will present a report similar to the one shown on the next page This will include the parameters and graphs corresponding to the selected curve If you do not want graphs certain parameters the diagnosis and or ATS ERS warnings to appear disable them as described in section 3 2 If you want a global printout of the report including the FVC VC and MVV tests made on a patient follow the steps described in the General Report Printout section 511 00 02 REV 2 03 Sibelmed 7 DATOSPIR MICRO User s Manual 129 DATOSPhETR MICRO HABEL ROSSELLO PULMONARY FUNCLLON
78. con keys Model A ora touch screen Models B and C 511 A00 MU2 REV 2 03 suoneoyi2eds 6 193deu Chapter 5 Technical Specifications 5 7 DATOSPIR MICRO User s Manual 200 Comunication channel e RS 232C e USB 2 0 Bluetooth 2 0 Printer e Compatible with HP PCL black and white or color printers 5 4 PRESENTATION OF DATA LCD Liquid Crystal Display of 2x16 Model A or high resolution touch screen LCD Liquid Crystal Display with array of 240 x 160 points Models B and C By external printer By PC with the corresponding software 5 5 TEMPERATURE SENSOR Internal temperature sensor from 0 to 50 C 2 C 5 6 GENERAL DATA Relative humidity e Less than 95 without condensation Barometric pressure Between 525 and 800 mmHg Between 699 9 and 1066 7 hPa approx 3000 to 400 metres altitude Temperature e Storage between 5 and 70 C e Working between 5 and 40 C 511 00 02 REV 2 03 Sibelmed 7 DATOSPIR MICRO User s Manual 201 Power supply e 1 5 V battery alkaline recommended or 1 2 NiMh battery recommended gt 2200mAh Power e Below 400 mW Size 153 5 x 80 52 mm Weight e 250g Useful life e Device 7 years e Turbine up to 1400 disinfections Applicable standards ELECTRONIC DEVICE 2011 65 EU Rohs Directive From July 22th 2014 MEDICAL DEVICE 93 42 CEE Directive RD 1591 2009 ELECTRICAL SAFETY e EN
79. cro to a non medical equipment with earth conductor it must be installed an aditional earth protective conductor to the non medical equipment The equipment must be stored and used within the temperature pressure and humidity margins specified RISKS OF EXPLOSION Do NOT use the equipment in the presence of anesthetics or inflammable gases THIS MAY CAUSE AN EXPLOSION RISKS OF CONTAMINATION Turbine transducer To avoid the risk of contamination or cross infection the turbine must be disinfected as indicated in this manual Mouthpieces Reusable mouthpieces must also be disinfected Disposable mouthpieces must not be reused 511 A00 MU2 REV 2 03 Safety 6 DATOSPIR MICRO User s Manual It s recommended the use of antibacterial filters when is used with infected patients or when a risk of contamination is suspected Pulse oximeter finger clip Although unlikely the organisms can also be transmitted by pulse oximetry Therefore the pulse oximeter finger clip should be washed with each patient change using either soapy water or a glutaraldehyde solution Instrunet type RISKS OF INTERFERENCE This is an electronic product so high frequency emissions can interfere with the correct use For this reason 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
80. cuit except for the RS 232 series communications channel interface and the screen controller QUALITATIVE DESCRIPTION The control programme is responsible for ensuring the spirometry signals are handled in line with the applicable standards particularly the calculation of Identification of the start of expiration The start of the test is determined by the filling of a maximum level of flow of approximately 100ml s although the immediately inferior values are not rejected Retrograde extrapolation The start of the FVC manoeuvre is established through retrograde extrapolation according to A T S criteria Identification of the end of expiration The end of the FVC manoeuvre is established according to A T S criteria i e when the volume accumulated in the last second is below 30ml Calibration programme 511 A00 MU2 REV 2 03 S belmed DATOSPIR MICRO User s Manual 211 Turbine Any ageing of or accumulated dirt in the turbine transducer may lead to imprecise measurements To ensure the turbine measures correctly the system includes a simple checking procedure based on measuring the known volume of a calibration syringe 6 4 PULSE OXIMETER The DATOSPIR MICRO includes an electronic module exclusively for taking Oxygen Saturation and Pulse Rate samples This module is powered by the motherboard and communicates with it through a specific series port The pulse oximetry measurement principle is based on the
81. d PR signal according to the screen time selected The top left shows the relative time at the start of the study hh mm ss Each channel allows for a dotted line of references to be displayed that can be selected by the user during configuration This line may be extremely useful when checking whether the samples exceed a certain value 511 00 02 REV 2 03 S be med 7 DATOSPIR MICRO User s Manual 147 PRINTING AND OR MEMORISING THE DATABASE The parameters are calculated upon accessing this screen This option may take a few seconds depending on the length of the study Press the key to access the parameters screen PARAMETERS B E 3 3 3 3 8 Exits this screen and goes back to the previous one E Prints the study report Saves Parameters Database 4 and Moves around the different parameters Once a test has been saved on the Database it can be retrieved in the same manner as any spirometric test The parameters calculated to display print or save on the Database are as follows 511 A00 MU2 REV 2 03 2 pue g sjapow 1e3deu Chapter 3 Models C Operation DATOSPIR MICRO VIT M Manual 148 90 of time in which 5 is below 90 CT80 of time in which SpO is below 80 70 of time which SpO is below 70 IDH 4 Desaturation index gt 4 per hour IDH 3 Desaturation index
82. d the auto check information to the SIBEL S A After sales Service or to your distributor who will analyse 511 A00 MU2 REV 2 03 Sibelmed 7 DATOSPIR MICRO User s Manual 187 it and assess the cause of the problem providing or proposing a suitable solution W20 Spirometry Software in demo mode or enabled is required to transfer this information The programme in demo mode is included as standard with the equipment The process to follow is 1 Start the DATOSPIR MICRO and select Maintenance from the Main screen Access the Equipment Check option and run all the suboptions following the instructions on the screen 2 Connect the equipment and the PC by series port USB or Bluetooth the previously installed W 20 Spirometry Software making sure that the DATOSPIR MICRO is selected in Configuration Links and access the Configuration Utilities Download Data option The transferred information is saved in the DATA directory of the application in the files STATUS CSV Contains the errors detected CALIBRA CSV Contains the calibration data CONFIG CSV Contains the equipment customisation PRUEBAS CSV Contains the database tests GRAFXxx CSV Contains the graphs in Flow Time mode The files from the previous transfer are renamed with the extension OLD 4 If you want to view the information of any of the files load them using MICROSOFT EXCEL 511 A00 MU2 REV 2 03 5 lt
83. der these conditions the data obtained is approximately 10 below those obtained when the patient is seated In patients with a diaphragmatic or neuromuscular pathology the difference between the two positions may be up to 40 60 making the observation a useful piece of data to assess the repercussions of this pathology When working with a pneumotachometer the manoeuvre may be exclusively reduced to maximum expiration from the maximum inspiration position The correction of a manoeuvre will be judged by its start its progress and its completion observing the patient and the tracing of the graph The start must produce a clean sudden deflection the progress itself will draw a gentle upwards concave curve without rectifications and the end must be asymptotic and not perpendicular or sudden Volume Time The expired volume measured during a forced manoeuvre will be influenced by the selecting of its starting point This means that a manoeuvre starting criterion must be chosen and maintained consistently The so called retrograde extrapolation is the most consistent and accepted method by European and American laboratories and will be chosen unless other methods are 511 00 02 REV 2 03 S belmed DATOSPIR MICRO User s Manual 215 shown to be similar or to have equivalent results volume extrapolated using this method must be below 5 of the vital capacity or 150 ml without exceeding either of the two criteria T
84. dilating drug as described in the previous sections 2 Memorise the PRE test in the database to compare it in POST mode as explained in MEMORISING FVC TESTS in Section 2 4 3 Apply the dosage of bronchial dilating drug established by the specialist to the patient and wait for the standardised period 4 Go back using the 4 key to the Test Selection window and select using keys SPIROMETRY 4 Dilation 511 A00 MU2 REV 2 03 y 4 Chapter 2 Model A Operating Sibelmed 7 DATOSPIR MICRO User s Manual 68 Select the screen DILATION 1 PRE manoeuvres and press gt The tests memorised in PRE mode will then be displayed Select the PRE test with which it is to be compared and press 6 The proceed as indicated in Section 2 4 FVC TEST PROCEDURE The only variation is in point 5 as the 9o is weighted in relation to the observed values in Pre bronchial and Post bronchial mode If the printed report is requested the data is presented as shown below Three columns of data can be seen e PRE PRE bronchial dilator Observed Values e POST POST bronchial dilator Observed Values WGT weighted between the POST and PRE values 9oWGT 100 x 2 POST PRE POST PRE See J E Cotes Lung Function Assessment and Aplication in Medicine Blackwell Sci 4th Edition 1979 p52 53 511 00 02 REV 2 03 Sibelmed 7 DATOSPIR MICRO User s Manual
85. divided into Basic hardware control programme BIOS residing in the internal Flash of the Micro controller 128 KBytes Spirometry and equipment management programme and test database residing in the 2 MByte FLASH memory Non volatile 512 KByte RAM memory to save the equipment configuration status variables and calibration database Central Processing Unit CPU Communications controller Series USB and Bluetooth with the outside Clock Calendar Alarm PROGRAMME The control programme has been developed in assembler and in top level C language to ensure very fast time control and a structured programme It is divided into two parts the Bios in internal Flash and the application in external Flash MEMORY The storage capacity for temporary data for the customised equipment configuration and for the calibration database is 512 KB in non volatile RAM The test database has a maximum capacity of 1 MByte 511 A00 MU2 REV 2 03 9 193deu Chapter 6 Operating Principles Sibelmed DATOSPIR MICRO User s Manual 210 CPU This device manages and runs the process that is coded into the data forming the programme The Renesas H8S2144 micro controller is used as a CPU CONTROLLERS These are responsible for transferring data between the CPU and the other devices such as the keypad the screen and the printer They form part of the integrated micro controller cir
86. e saved using a six second FVC as reference are Database L 150 Database H 21000 The saving of the tests has already been described in the sections corresponding to each test The database always saves all the spirometric parameters of each of the different test modalities FVC VC MVV or Dilation despite them not being selected in the Customisation programme Different functions are possible from the spirometer 1 Search the database 2 Search for a patient 3 Search for a register 511 A00 MU2 REV 2 03 2 pue sjapow 1oe3deu Chapter 3 Models C Operation PLA DATOSPIR MICRO User s Manual 158 4 Print a summarised report 5 Delete the database To do so start the DATOSPIR MICRO using the key and wait for the following screen to appear DATOSPIA MICRO 18 10 Press to access the screen with the options to be chosen with the database Q3 05 06 DATABASE H 18 11 mn ESC l ESC Go back to the main screen 511 A00 MU2 REV 2 03 Sibelmed 7 DATOSPIR MICRO User s Manual 159 8 Search for patient Search for register Search the database Summarised report Delete the database DATABASE SEARCH Select the option to display the tests saved on the database REGISTER NUMBER Fat Code FEV1 ESC Go back to the previous screen and Fast back
87. e will appear WILL BE DELETED ARE YOU SURES Press the key to delete the manoeuvre Then the following message will appear to indicate that the manoeuvre has been deleted S be med 7 DATOSPIR MICRO User s Manual 131 OTHER TESTS ON THE SAME PATIENT You can do the following after carrying out the FVC test on a patient A VC test on the same patient An MVV test on the same patient A Post bronchial dilation test on the same patient Print the general report of all tests on the same patient Start the test process on another patient The spirometer saves the best manoeuvre of each FVC VC MVV and or Bronchial dilation test to print a general report where required of them all before going on to another patient CHANGE PATIENT This option is used to change some details of an existing patient or to enter a new patient Press the key on the test screen to access the patient s details screen Follow the procedure described in the ENTERING PATIENT PARAMETERS procedure to enter the details of a new patient or to modify the details of an existing patient NOTE In the event of having modified some details of an existing patient his parameters will be recalculated taking the changes made into account 511 00 02 e REV 2 03 2 pue sjapow 1oe3deu Chapter 3 Models C Operation Sibelmed DATOSPIR MICRO User s Manual 132 3 5 SLOW VITAL
88. ed DATOSPIR MICRO User s Manual 144 MAS reo 17 45 PULSE ORT SIGNAL ON MEMORY 8 00 96 112 EF Exits this screen and goes back to the previous Average SpO configuration and beeping sound Deletes the study from the memory Calculates and displays the value of the parameters Starts or stops saving a study Accesses the Trends screen Accesses the patient details screen e SPECIFIC TESTS In specific pulse oximetry studies the screen will indicate the SpO and PR values according to the average configured In order to print the results you must first save the signal by pressing during the period required and then following the instructions given in the PRINTING AND OR MEMORISING ON THE DATABASE section 511 A00 MU2 REV 2 03 Sibelmed 7 DATOSPIR MICRO User s Manual 145 LONG TERM TESTS In long term tests press the same button to begin saving A flashing message SAVING will appear in the centre of the screen to indicate that the study is being saved It is important to note that the signal is related to the patient code entered If the study is started or stopped without having previously changed the patient code or without deleting the study fragments of signal will be saved one after the other until the 8 hours are completed The equipment will interpret that all the fragments correspond to the same patient and the parame
89. een 80 and 50 Precaution RED Zone Between 50 and 0 Warning SEMAPHORE LEVELS Min xxx xxx Select the level where necessary and press gt alarms reminder for the patient as the test can be taken at any time despite it being different to the time programmed and the time it is taken is recorded DAILY TESTS None one two or three No of Tests x daily alarms for the test TEST 1 XX XX XX Time of the 1st test TEST 2 XX XX XX Time of the 2nd test TEST 3 XX XX Time of the 3rd test 511 A00 MU2 REV 2 03 Sibelmed 7 DATOSPIR MICRO User s Manual TEST DAYS Days of the week when MoTuWeThuFrSaSu the tests are taken Home mode is now configured so that you simply have to access the following option from the main screen to activate it MAIN MENU 6 Hospital mode Shows the current mode Press the to change mode and switch the equipment off ACQUISITION OF SPIROMETRIC TESTS Once the equipment has been configured by the specialist the test acquisition process can begin The storage capacity is 150 or 1000 tests depending on the database L or H The specialist will explain the test to the patient particularly the forced expiration manoeuvre process the equipment operating sequence and when the tests should be taken The operating sequence is as follows e If start up is manual the patient starts the equipment 1 The start screen will appear al
90. ent specified below The costumer or the user DATOSPIR MICRO should assure that it is used in such an environment EN IEC 60601 test Compliance le Electromagnetic environment level Guidance Immunity test Electrostatic discharge 6 kV contact 6 kV contact Floors should be wood concrete or ESD ceramic tile If floors are covered with 8 kV air 8 kV air synthetic material the relative humidity EN IEC 61000 4 2 should be at least 30 96 Electrical fast 2 kV for power supply DC USB 5V power transient burst lines EN IEC 61000 4 4 1 kV for input output lines The input output line cables are shorter than 3 meters long Surge 1 kV differential Not applicable DATOSPIR MICRO works with batteries DC USB EN IEC 61000 4 5 2 kV common mode Not applicable Voltage dips short lt 5 Ut Not applicable DATOSPIR MICRO works with batteries interruptions and voltage gt 95 dip in Ut DC USB variations on power for 0 5 cycle supply input lines 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 EN IEC 61000 4 11 Power freauency 50 Power frequency magnetic fields should 60 Hz magnetic field be at levels characteristic of a typical location in a typical commercial of hospital EN IEC 61000 4 8 environment NOTE Utis the a c mains voltage prior to application of the test level 511 A00 MU2 REV 2 03 xip
91. entilation Test Start manoeuvre Results Save DB Save PRE Report Delete New patient 4 Dilation Post bronchial dilation test 1 PRE manoeuvres 1 Start manoeuvre Results Diagnosis Save DB Report Delete Delete PRE NOU 5 Total Report 6 New Patient 511 A00 MU2 REV 2 03 y 4 Chapter 2 Model A Operating Sibelmed 7 DATOSPIR MICRO User s Manual 36 AUN 4 2 CALIBRATION Calibration DB calibration 1 Register Data 2 Delete Register 3 Report DATABASE Search DB 1 Results 2 Diagnosis 3 Report 4 Delete test Search patient Search register Summarised report Delete DB CUSTOMISATION Spirometry 1 References 1 Adults 2 Children 3 Ethnic Factor 2 Parameters 1 FVC 2 VC 3 MVV Graphics Diagnosis Dilation modes Warnings au RW Home mode 1 Patient details 2 Test data 511 A00 MU2 e REV 2 03 Sibelmed 7 DATOSPIR MICRO User s Manual UI Printers Standard 1 Retrieve standard 2 Modify standard Battery Language Set clock Pin MAINTENANCE Warnings LCD contrast Equipment check 1 Printer 2 CPU 3 LCD 4 Keypad 5 ADCs 6 Inputs Equipment config 1 Reset 2 Reindex 3 Calibrate 4 VC mode 5 Update PIN ATS curves 1 FVC 2 VC 3 MVV OPE
92. er of errors in the write read process OxFFEFOO Err CPU Ram 0 4 Tests the external RAM the same process as for the internal RAM Ox81E000 Err Ext Ram O QUIPMENT CHECK 5 Auto On Off to check that the automatic on and off of the equipment works properly On selecting this option the equipment switches off and on automatically after 5 seconds 511 A00 MU2 REV 2 03 Sibelmed 7 DATOSPIR MICRO User s Manual 85 EQUIPMENT CONFIGURATION Select the option MAINTENANCE 4 Config Equip y z 4 This option allows for different options of the equipment to be configured Using keys Jana v select CONFIG EQUIP 1 Reset to reset all equipment variables CONFIG EQUIP 2 Reindex to reindex the database CONFIG EQUIP 3 Calibration to enter the turbine pulses CONFIG EQUIP 4 VC mode to choose the presentation mode for the VC curve Normal expiration upwards Inverted expiration downwards 511 A00 MU2 e REV 2 03 Chapter 2 Model A Operating S belmed DATOSPIR MICRO User s Manual 86 CONFIG EQUIP 5 Update Key to consult the updating key for the programme in Flash ATS CURVES Select the option MAINTENANCE 5 Standard Curves This option checks the correct working order of the equipment using pre saved curves Using keys select STANDARD CURVES 1 FVC STANDARD CURVES 2 VC STANDARD CURVES 3 MVV
93. es have been completed and the FVC and or FEV1 signs are flashing this indicates that the repeatability criterion for one or both parameters has been met according to the ATS ERS This criterion indicates that the best two observed values of FVC and the best two of FEV1 differ in no more than 150 ml if the FVC is greater than 1 litre or in no more than 100 ml if the FVC is below or equal to one litre ESC NOTE Remember that by using the back key lt it is possible to go backwards in the menu without losing the information available to date unless you change patient by entering a new code or on another occasion although this is previously indicated on screen ATS ERS criteria The manoeuvre with least warnings is considered the best ET EX With the same number of warnings the manoeuvre with the highest value sum of FVC FEV1 is considered the best Chapter 3 Models C Operation Sibelmed DATOSPIR MICRO User s Manual 122 DISPLAYING RESULTS Press the parameter area The data on the selected manoeuvre will be displayed M1 by default Go back to the previous screen Change manoeuvre Display the diagnosis of the selected manoeuvre Print the report on the selected manoeuvre lt i ESI s Save the selected manoeuvre in the database 4 d Display the remaining parameters if selected e The screen displays the values of Reference the Observed values and the 9o between both pa
94. es the best manoeuvre of each FVC VC MVV and or Bronchial dilation test to print a general report where required containig them all before going on to another patient From the next screen and using keys or select any of the first four options CHANGE PATIENT This option is used to enter a new patient or to change some details of an existing patient The process is similar to that described in the previous section but previously selecting the option FVC TEST 8 New patient Press the gt key the following screen will appear PATIENT DETAILS Code 0000000000 Enter the patient code required between 0000000000 and 9999999999 511 A00 MU2 REV 2 03 y 4 Chapter 2 Model A Operating Sibelmed 7 DATOSPIR MICRO User s Manual 62 If you wish to modify some details of an existing enter his code Follow the procedure designed in the ENTERING PATIENT PARAMETERS procedure to enter the details of a new patient or to modify the details of an existing patient If you have not saved the tests completed to date the following warning will appear after the last screen of data DELETE UNSAVED TESTS If you press the tests completed will be saved the database If you press gt the tests completed will not be saved in the database and CANNOT BE RECOVERED All the tests completed will then belong to the new patient NOTE In the event of ha
95. f the safety systems adjustments and functions etc forming the equipment THIS TECHNICAL CHECK WILL BE PERFORMED EVERY YEAR and in line with the DATOSPIR MICRO Verification and Adjustment Procedure available from the manufacturer This type of operation must be carried out by skilled technical staff from the hospital s maintenance department or from the distributor s or manufacturer s technical service 511 00 02 REV 2 03 Sibelmed DATOSPIR MICRO User s Manual 225 On all accounts SIBEL S A as the manufacturer must provide written authorisation for at least the guarantee period for the corresponding technical personnel to carry out said maintenance and will not be held liable under any circumstances for any damage malfunction etc that may arise as a result of defective maintenance by people not belonging to SIBEL S A 8 3 CORRECTIVE MAINTENANCE Corrective maintenance consists of leaving equipment that has stopped working and must be repaired due to malfunctioning or misuse in a good state of repair Where a fault is detected in the equipment which prevents it from being used normally contact the SIBEL S A After Sales Service and specify the problem in as much detail as possible 511 A00 MU2 REV 2 03 941729110 pue deexdp g 1o3deu Chapter 8 Upkeep Preventative and Corrective Maintenance Sibe med DATOSPIR MICRO User s Manual 226 511
96. h the following symbol Note 1 At 80 MHz and 800 MHz the higher frequency range applies Note 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people 3 Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which DATOSPIR MICRO is used exceeds the applicable RF compliance level above should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such reorienting or relocating DATOSPIR MICRO bOver the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m 511 A00 MU2 REV 2 03 5 DATOSPIR MICRO User s Manual Recommended separation distances between portable and mobile RF communications equipment and DATOSPIR MICRO 231 equipment Rated Maximum output DATOSPIR MICRO is intended for use in an electronic environment in which radiated RF disturbances are controlled The costumer or the user of DATOSPIR MICRO can help prevent electr
97. he FEV1 Reference Values in the range of reference Normal Diagnosis If FEV1 FVC lt FEV1 FVC Reference FEV1 80 of the FEV1 Reference 511 A00 MU2 REV 2 03 y 4 Chapter 2 Model A Operating Sibelmed 7 DATOSPIR MICRO User s Manual 54 Obstructive ventilatory disturbance FEV1 80 Slight FEV1 65 Moderate FEV1 lt 50 Intense FEV1 lt 35 Very Intense If FEV1 FVC lt FEV1 FVC Reference and FVC lt 80 of the FVC Reference Non obstructive ventilatory disturbance FVC lt 80 Slight FVC 65 Moderate FVC lt 50 Intense FVC lt 35 Very Intense If FEV1 FVC lt FEV1 FVC Reference and FVC gt 80 of the FVC Reference Mixed ventilatory disturbance is suspected If FEV1 FVC lt FEV1 FVC Reference FEV1 gt 80 of the FEV1 Reference Mixed ventilatory disturbance is suspected If the POST bronchial dilation test is carried out and the FEV1 POST exceeds the base FEV1 or PRE by 1596 There is a positive response to the bronchial dilating drug MEMORISING FVC TESTS Memorising a test in the Internal Database The DATOSPIR MICRO spirometer has an Internal Database that can save different tests to be subsequently transferred to a PC Database using W20 Spirometry Software This base may be of the L or H depending on its capacity The process is similar to that described in the DISPLAYING RESULTS section although previously selecting the
98. he patient it must be kept in perfect physical and hygienic conditions To do so proceed as follows 1 turbine is removed from the equipment housing by pressing slightly so that is comes away from its fixtures 2 Wash the turbine with water and soap avoiding solvents or abrasive substances that may damage the components Given that its reliability depends on the condition of the turbine make sure it is not damaged Once rinsed avoid salt deposits by rinsing again with distilled water 4 You can then leave it to dry at room temperature 5 Reassemble the turbine the housing 511 A00 MU2 REV 2 03 Sibelmed DATOSPIR MICRO User s Manual 223 Top level disinfection If you suspect microbial contamination use one of the more complex antiseptic solutions or sterilisation procedures For example replace Step 2 by submerging it in a glutaraldehyde solution or similar for 10 minutes follow the manufacturer s instructions PRECAUTION DO NOT EXPOSE THE TURBINE TO TEMPERATURES OF OVER 60 C OR BELOW 0 C DO NOT USE SOLVENTS OR OTHER SIMILAR SUBSTANCES FOR CLEANING AS THEY MAY DAMAGE IT SPIROMETER The spirometer is cleaned gently with a dry cloth or a cloth dampened slightly with soapy water with any remains of water then being dried Pay special attention to ensure no liquid enters the inside or connectors and connections Do not use abrasive substances or solvents WARNING Remove the batteries f
99. he protection is disabled and the PIN is set to 0000 See Section 2 2 3 2 EQUIPMENT CUSTOMISATION to enable it and configure the PIN HANDLING THE EQUIPMENT The spirometer has been developed to make it user friendly so that it is easy and simple to use The equipment may seem difficult to handle given its multiple functions although its design and use will quickly show you that it is truly easy and intuitive for any medical staff All functions are accessible from the 4 silicon keys located underneath the screen Model A or using the icons on the screen that be selected using a pointer Models and C All models can be connected as standard or optionally to an external printer where this has been previously selected in the Customisation option In this case following the instructions of the corresponding printer 1 6 OPERATING MODES The DATOSPIR MICRO spirometer has two operating modes e HOME Mode e HOSPITAL Mode Each one is selected from the main screen HOME MODE This operating mode means that the DATOSPIR MICRO can be programmed to control asthmatic patients at home 511 A00 MU2 REV 2 03 S belmed DATOSPIR MICRO User s Manual 31 See section 2 12 3 13 HOME MODE OPERATION The equipment is very simple and easy to handle presenting the measured value of PEF FEV1 or FVC in a colour range of Green Yellow and Red semaphore as programmed Spirometer operations by patients at home are saved in
100. he risk of EPOC e Age of the Lung Parameter that depends on the height and FEV1 Indicates the equivalent age of the lung According to ERS ATS standardisation parameters MEF25 MEF50 MEF75 are replaced by FEF75 FEF50 FEF25 Diagnosis based on e Miller Quadrant e Snider Kory amp Lyons Percentage deviation in relation to values of reference Standardised values of reference that can be selected from several standards Patient s ID details Atmospheric data on temperature pressure and relative humidity 511 A00 MU2 REV 2 03 suoneoyi2eds e2iuu2o 1 6 193deu Chapter 5 Technical Specifications Sibelmed 7 DATOSPIR MICRO User s Manual 194 Graphs in FLOW VOLUME and VOLUME TIME Warnings of manoeuvre compliance with ATS ERS criteria Saving of five manoeuvres from the same test Acoustic and graphic indication of the start and end of each manoeuvre SLOW VITAL CAPACITY Parameters e VC l Slow vital capacity e TV 1 Tidal volume e ERV 1 _ Expiratory Residual Volume e IRV 1 Inspiratory Residual Volume e 1 Inspiratory Capacity e Ti s Inspiratory time e Te s time e Tt s Total time e Ti Tt Ratio Percentage deviation in relation to values of reference Standardised values of reference that can be selected from several standards Patient s ID details Atmospheric data on temperature pressure and relative humidity Graphs in VOLUME
101. his calibration factor must take the changes in volume associated to atmospheric conditions temperature relative humidity and barometric pressure into account The most influential factor is temperature followed by the humidity level The DATOSPIR MICRO includes a Calibration Programme for fast less than one minute and easy checking and auto correcting of deviations in the measurements taken based on a standard or reference volume for the quality control of the different spirometric tests The regularity of calibration depends on the user although the standards recommend it be done on a daily or weekly basis CALIBRATION PROCESS The calibration process is as follows 1 Install the spirometer and the syringe as in the figure 511 A00 MU2 REV 2 03 uonesdo 2 pue g sjapow 1oe3deu Sibelmed DATOSPIR MICRO User s Manual 152 MANGUERA REGISTRO 75 JERINGA DE CALIBRAC KON dale Jels 2 From the Main screen press the key e The following screen will appear x EXP F 4 008 TMSP 1 04 3766 5 ER volumes Pulses Pres of 67 ETE If there are previous calibrations the details of the last one will appear in the title Enter the necessary data qe Volume volume of the syringe between 0 6 litres depending on the syringe If a 0 is entered the default factors are used Fct 1 and NPulses 188 a
102. ial Statement of the European Respiratory Society Luxembourg 1993 Variable Sex Equation Age 18 70 RSD 1 64RSD FVC M 5 76H 0 026A 4 34 0 61 1 00 F 4 43H 0 026A 2 89 0 43 0 71 4 30H 0 029A 2 49 0 51 0 84 3 95H 0 025A 2 60 0 38 0 62 FEV1 FVC M 0 18 87 21 7 17 11 80 0 19 89 10 6 51 10 70 25 75 1 94 0 043A 2 70 1 04 1 71 1 25 0 034 2 92 0 85 1 40 PEF M 6 14H 0 043A 0 15 1 21 1 99 F 5 50H 0 030A 1 11 0 90 1 48 FEF 75 FVC 5 46H 0 029A 0 47 1 71 2 81 F 3 22 0 025A 1 60 1 35 2 22 FEF 50 3 79H 0 031A 0 35 1 32 2 17 F 2 45H 0 025A 1 16 1 10 1 81 FEF 25 2 61H 0 026A 1 34 0 78 1 28 F 1 05H 0 025A 1 11 0 69 1 13 M male F female H height m A age years RSD Residual Standard Deviation According to ATS ERS standardisation parameters MEF25 MEF50 MEF75 are replaced by FEF75 FEF50 and FEF25 Between the ages of 18 and 25 25 is replaced in the equations 511 A00 MU2 REV 2 03 Asyowosids 193deu 5 Chapter 7 Spirometry Technique Sibelmed DATOSPIR MICRO User s Manual 220 IMPORTANT NOTE The DATOSPIR MICRO spirometer allows for an ETHNIC FACTOR to be entered which modifies the values of reference for certain groups of the population This factor ranges from 80 to 120 of the values of reference where 100 is the value according to each table
103. ibelmed DATOSPIR MICRO User s Manual 172 In the case of the former consult the key in the equipment before starting the update process Switch the DATOSPIR MICRO on and from the main menu select Select and consult the update key that appears on the screen Switch off the DATOSPIR MICRO The updating process is as follows 1 Run the W 20 Spirometry Software and access the Configuration Hardware Test option Run a communications test to check that the connections are correct 2 Switch off the DATOSPIR MICRO 3 Start the DATOSPIR MICRO while keeping the top right of the screen pressed down This runs the programme in BIOS to update FLASH 4 The BIOS access key press 3 and then 4 is then requested to prevent any user from accessing it by mistake 5 the new file provided by SIBEL containing the update DMFlash tsk to the FIRMWARE directory of the application W20 6 Run the W 20 Spirometry Software access the Configuration Links option and check that the DATOSPIR MICRO is selected 511 A00 MU2 REV 2 03 Sibelmed 7 DATOSPIR MICRO User s Manual 173 7 Access the Configuration Utilities Update Flash option the W 20 Spirometry Software in demo mode provided upon purchasing the equipment is enough A dialogue box will open where the update key the one previously consulted if this is a version update or the one provided by SIBEL if it is an option update must be entered 8 The new
104. ibration should only be used as a guideline and in the event of no syringe being available CALIBRATION REGISTERING The spirometer has a register containing the expiratory and inspiratory factors of the last ten calibrations performed This is extremely useful for centres requiring a quality control of the processes they use To do so press on the first calibration process screen The following screen will appear 511 A00 MU2 REV 2 03 2 pue g Chapter 3 Models C Operation Sibelme d DATOSPIR MICRO User s Manual 156 REGISTER 1 3 Deletes register Prints existing registers Moves around the different calibrations The information shown is Number of registers available Date of calibration Time of calibration Volume of calibration Expiratory factor Inspiratory factor 511 A00 MU2 REV 2 03 S be med 7 DATOSPIR MICRO User s Manual 157 3 10 INTERNAL DATABASE The DATOSPIR MICRO has an Internal Database as standard which saves the different tests made using the equipment and subsequently displays them prints them and or transfers them to a PC or other computerised system for storage or management The base information remains even when the equipment is unplugged There are two bases with the same functions but different capacities Database L Database H The tests that can b
105. iguration to date can be saved for use as standard BATTERY CUSTOMISATION The DATOSPIR MICRO works with two types of battery alkaline or NiMh independent to the battery selected in this section This selection only affects the calculation made inside the equipment to indicate the battery levels LANGUAGE CUSTOMISATION This option allows for the equipment language to be chosen SET CLOCK This option sets the time and the date of the clock inside the equipment 511 A00 MU2 REV 2 03 Sibelmed 7 DATOSPIR MICRO User s Manual 41 EQUIPMENT PROTECTION CUSTOMISATION This allows you to change the PIN required to start the equipment if the protection option is enabled and to enable or disable equipment protection The following screens will appear successively CHANGE PIN Current Pin 0000 CHANGE PIN Pin Enabled Yes CHANGE PIN New 1 0000 CHANGE PIN New 2 0000 To enable protection select YES on the Pin Enabled screen and enter the PIN in the New 1 and 2 screens To change the PIN you must enter the current one If an erroneous PIN is entered three times the equipment will lock and will switch off See the following section 2 3 EQUIPMENT PROTECTION 511 A00 MU2 REV 2 03 y z 4 Chapter 2 Model A Operating Sibelmed 7 DATOSPIR MICRO User s Manual 42 2 3 EQUIPMENT PROTECTION If equipment protection has been enabled the following screen will ap
106. ined If this is not possible working order of the appliance must be checked using control individuals i e people close to the laboratory and whose cooperation is attainable to carry out correct spirometry with easy and scarce variability Table I so that their spirometry can be regularly reproduced and compared with the previous data Hence errors can be detected that would have to be significant in size as the variability of spirometry itself prevents small differences in the measuring of volume and flow from being detected see Table I Under normal working conditions calibration using the volume signal provided by a manual syringe will be performed on a daily basis The signal provided by the syringe must be produced with different pulses to check whether the flow reading remains steady as the appliance must always integrate the signal in the same volume that provided by the syringe signal whatever the suddenness of the injection manoeuvre with the upper limit of the flow range precisely measured close to the real value by the instrument in question not being exceeded Calibration with a dynamic signal produced by the explosive decompressor or the measuring of spirometry on control individuals as mentioned above may be performed relatively less often It is wise to perform calibration using the decompressor every fortnight in the case of pneumotachometers Given that spirometry with control 511 A00 MU2 REV 2 0
107. ining in spirometry is recommended User must be familiarized with the functioning of the device before beginning to perform tests with patients All necessary information can be found in the user s manual For more information consult SIBEL S A or your regular distributor PULSIOXIMETRO OPCIONAL Pulseoximeter must be used at least under the supervision of a physician EFFECTS ON PATIENTS USING THE SPIROMETER The spirometry tests require patient cooperation Complete forced expiration is required to obtain significant patient FVC values The doctor must assess the patient s capacity to undertake spirometry tests Special attention must be paid to children the elderly and the disabled 511 00 02 e REV 2 03 6 DATOSPIR MICRO User s Manual LIMITATIONS USE CONTRAINDICATIONS analysis of the results of a spirometry tests is not enough itself to give a correct diagnosis of the patient s clinical condition The patient s records and any tests that the doctor believes necessary must therefore also be considered A doctor must interpret the tests and any treatment provided as a result The patient s symptoms must be taken into account by medical staff before any spirometric test is undertaken Acceptability of a test is the responsibility of the medical staff The spirometer must not be used when the validity of the results is likely to be jeopardised by external fac
108. ions test to check that the connections are correct 2 Switch off the DATOSPIR MICRO 3 Start the DATOSPIR MICRO while keeping the key pressed down This will run the 511 A00 MU2 REV 2 03 y 4 Chapter 2 Model Operating S belmed DATOSPIR MICRO User s Manual 90 programme in BIOS to update FLASH 4 The BIOS access key is then requested Press lt then gt to prevent user from being able to access by mistake 5 the new file provided by SIBEL containing the update DMFlash tsk to the FIRMWARE directory of the application W20 6 Run the W 20 Spirometry Software access the Configuration Links option and check that the DATOSPIR MICRO is selected 7 Access the Configuration Utilities Update Flash option the W 20 Spirometry Software in demo mode provided on purchasing the equipment is enough A 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 8 The new programme will be transmitted The process may take around 10 minutes depending on the PC Switch off the DATOSPIR MICRO 511 A00 MU2 REV 2 03 S be med 7 DATOSPIR MICRO User s Manual 2 12 HOME MODE OPERATIONS The DATOSPIR MICRO spirometer is very useful to monitor and control asthmatic patients or others to suit the specialist s
109. ired Where enabled a screen will appear requesting the PIN user configured when the equipment is started If an erroneous PIN is entered three times the equipment will lock and will switch off On restarting it a screen will appear requesting the unlock code or PUK supplied to the purchaser of the equipment This prevents access to the equipment and more specifically to the private data it contains by unauthorised people For information on the Data Protection Act LOPD consult APPENDIX 2 511 00 02 REV 2 03 Sibelmed 7 DATOSPIR MICRO User s Manual 29 START UP To start the DATOSPIR MICRO spirometer press the key The equipment will then make beeping sound and will check itself The logo the name of the equipment the programme version and the address of SIBEL S A will appear on screen for two seconds If equipment protection is enabled the PIN entry screen will appear If equipment protection is not enabled or if the correct PIN has been entered the MAIN MENU will then be displayed which varies according to the model Model A MAIN MENU 1 Spirometry Modelos C 050106 DATOSPIA MICRO 10 511 A00 MU2 REV 2 03 pue esr 10 2 1 T 1e3deu Chapter 1 Instructions for Use and Installation Sibelmed DATOSPIR MICRO User s Manual NOTE The first time the equipment is started t
110. l 5 Dilation modes The comparison mode can be selected in POST bronchial dilation 6 Warnings The printing of Non conformity warnings regarding the operations with ATS ERS criteria can be selected CUSTOMISATION OF THE HOME MODE In this option it is possible to configure the DATOSPIR MICRO for use in home mode See Section 2 12 HOME MODE OPERATIONS PRINTER CUSTOMISATION In this option you can choose if you want to print in black and white or color The Datospir Micro works only with HP PCL printers To be able to print from the equipment you must 1 Select the type of printer connected to the equipment once this has been done you will not have to repeat this step unless the printer is changed 2 Connectthe equipment to the external printer using the Mini USB cable code 305 600 040 included depending on model 3 Switch the printer on 511 A00 MU2 REV 2 03 y 4 Chapter 2 Model Operating Sibelmed 7 DATOSPIR MICRO User s Manual 40 STANDARD CONFIGURATION This option memorises a user defined customisation programme status to retrieve it at any time globally and automatically This option restores the original customisation if it has been modified either voluntarily or by accident In general this configureation will correspond to that most often used 1 Retrieve Standard The configuration saved can be loaded as standard 2 Modify Standard The conf
111. lla com 174 Pesoc Egl 68 26 760 BD 1 Kuma D Referencias F ELnico t 100 Motivo Pr ocedeuceia T cnico ver Bigz 5115AB 1 00 SLIEAF 00 INFORME DE MANHIQDEA 171 PARAMET HO ORS LE Mejor FYC 99 5 45 112 Mejor 1 4 26 1 27 100 1 5 uu 5 25 118 1 4 25 4 97 V 50 44 1 7 amp Gf ID Ta hc Up 9 lye 3 78 5 52 bg FEFP2RhE Thy 2 42 4 450 REVU 5 1 55 1 45 107 X 10 93 ComenrsticB oni eee ee oos ea xum bea eee ded Via 51 a d a A E E 1 4 4 duct tut 1 14 511 00 02 2 03 Sibelmed 7 DATOSPIR MICRO User s Manual This will include the parameters and graphs corresponding to the selected curve If you do not want graphs certain parameters the diagnosis and or ATS ERS warnings to appear disable them as described in Section 2 2 EQUIPMENT CUSTOMISATION WARNING REMEMBER THAT THE BEST MANOEUVRE CORRESPONDS TO THE ONE SAVED IN POSITION 1 AND WILL BE SELECTED BY DEFAULT If you want a global printout of the report including the FVC VC and MVV tests made on a patient follow the steps described in the General Report Printing Section The following screen will appear during the printing process PRINTING EBENEN The top line indica
112. lses 188 and the calibration process is completed NOTE Where no syringe is available the value entered in Volume is not relevant and is not taken into account when automatically calibrating the equipment 6 Press gt The following screen will appear CAL DATA No Pulses xxx If the number of pulses associated to its turbine is as appears on screen continue without modifying it If it is different enter the number of turbine pulses In this case press and the following message will appear Confirme cambio de N Pulsos Press gt the factors will be calculated and the calibration process will conclude In case of pressing the number of pulses will not change 511 A00 MU2 REV 2 03 Sibelmed 7 DATOSPIR MICRO User s Manual 73 and will return to the previous screen NOTE Each turbine is factory calibrated individually and is associated to a factor equivalent to the pulses litre detected and printed on it Although dispersion among turbines is within 3 it is worth entering this factor in the spirometer if the turbine is changed to obtain the maximum measurement precision Where no syringe is available it is very important to enter the No of Pulses of the turbine so that the equipment can be automatically calibrated 7 Press gt The atmospheric temperature 9C detected will appear thanks to a sensor inside the equipment This can be modified if required CAL DATA Temp 9C x
113. ly selecting the option FVC TEST 5 Save PRE Press the gt key and a similar screen to the following will appear depending on the number of manoeuvres made SAVE PRE M1 M2 M3 M4 M5 Select the manoeuvre to be saved using the keys and v appearing between brackets and press gt 511 A00 MU2 REV 2 03 Sibelmed 7 DATOSPIR MICRO User s Manual 57 The following screen will appear for a few seconds MANOEUVRE PRE N X SAVED If you have made a mistake or wish to modify the manoeuvre repeat the process PRINTING THE FVC The DATOSPIR MICRO spirometer can print any manoeuvre made using an external printer The process is similar to that described in the previous section but previously selecting the option FVC TEST 6 Report Press the gt key and a similar screen to the following will appear REPORT M1 M2 Check that the printer is ready and connected Select the manoeuvre to print flashng text and press gt The best M1 is recommended 511 A00 MU2 REV 2 03 y 4 Model A Operating Chapter 2 Sibelmed 7 DATOSPIR MICRO User s Manual The printer will present a report similar to the following Sibelmed DATISPIR MICE ATERT 500 GROUSE BAECELONA W UNCTON TIM MONAR JIA LEE MICRO codigo 910600001 00704 2006 Hara 1 44 Nombres Hombro Rdad al Ta
114. me This rotation is detected by the interrupting of a beam of infrared light the sensor of which converts the light received into a digital type electrical signal 6 1 TURBINE The turbine is axial with two stators in the form of a propeller and a rotor made up of a flat rectangular blade The shape of the stators means that the air flow passing turns which makes the blade turn The turbine operates based on the Fluid Mechanics theory and more specifically the Machine Turbo theory Applied to this case the angle at which the rotor turns is directly proportional to the fluid volume crossing the turbine and the proportionality constant depends on its shape 6 2 TURBINE ROTATION SENSOR The turbine rotation sensor consists of three pairs of emitting diodes and an infrared invisible photo transistor that appropriately positioned detect the rotation and its direction The number of times the beam is interrupted is equivalent to an accumulated angle of rotations and therefore the voluem of air to have crossed the turbine The photo transistor provides a digital electrical signal that represents the times the beam of light is interrupted and is directly acquired by the microprocessor 511 00 02 REV 2 03 S belmed DATOSPIR MICRO User s Manual 209 6 3 MICROPROCESSOR PHYSICAL DESCRIPTION The microprocessor system is made up of a series of electronic devices that save manage receive and send data In general terms it is
115. me mode customisation includes the customisation of the patient s details and the test data Press and enter the patient s details Oda 7 Cedi L Code xxxxxxxxxx Between 0 and 9999999999 Sex Between male and female C d xxx Between 0 and 100 cigarettes day Age xx Between 4 and 100 Cm xx Between 50 and 230 cm Kg xx Between 15 and 200 Kg Press to configure the semaphore and the alarms Select the parameter of reference for the manoeuvres and ress Sibelmed DATOSPIR MICRO User s Manual 176 The value of REFERENCE will then appear depending on the age height etc of the patient and the tables enabled in the Customisation programme This value can be changed by the specialist for patients who under controlled asthma conditions have a significant deviation with regard to the reference standard The value programmed will be equivalent to 100 in the subsequent control Select the value where necessary REFERENCE VALLE The levels must be defined in percentages in relation to the value previously selected from among the different semaphore indicators The standard levels are GREEN Zone Between 100 and 80 Normal YELLOW Zone Between 80 and 50 Precaution RED Zone Between 50 and 09 Warning Select the level where necessary SEMAPHORE LEVELS Min Leuel x1 Level x1 Sibelmed 7 DATOSPIR MICRO User s Man
116. n The following screen will appear with the information on the latest 511 A00 MU2 REV 2 03 S be med 7 DATOSPIR MICRO User s Manual maintenance work the tests performed and the tests performed since the last maintenance work WARNING SELECTION Last Maintenance O36 2806 Total Tests Tests Since Last Maintenance Press WARNING SELECTION Calibration Period Maintenance Period This screen defines the periods in days between calibrations or between preventative maintenance work on the equipment If the days specified without calibration or maintenance are exceeded the equipment warns of such by displaying a sign every time it is started If O days is entered a warning is never given LCD CONTRAST Select the option Ll to configure the screen contrast 20 02 REV 2 03 Chapter 3 Models C Operation Sibelmed DATOSPIR MICRO User s Manual AKA LCD CONTRAST Go back to the previous screen White background black content ESI s Black background white content m Validate choice n and Increase decrease contrast EQUIPMENT CHECK Select the option to check different parts of the equipment CHECK EQUIPMENT 15 45 511 00 02 166 REV 2 03 Sibelmed 7 DATOSPIR MICRO User s Manual 167 ESC Go back to the previous screen Distrib
117. nd the main screen will appear If an erroneous PIN is entered three times the equipment will lock and switch off The following screen will appear when it is restarted ENTER CODE OHA Enter the unlock code supplied upon purchasing the equipment and press Sibelmed 7 DATOSPIR MICRO User s Manual 113 If the correct code is entered the DATOSPIR MICRO will unlock and the main screen will appear From then on the equipment will return to its initial status Protection disabled and PIN 0000 If an erroneous code is entered the equipment will remain locked This prevents unauthorised access to the equipment and more specifically to the private data it contains 511 A00 MU2 REV 2 03 uonejodo 2 pue sjapow Chapter 3 Models and C Operation Sibelmed DATOSPIR MICRO User s Manual 114 3 4 FORCED VITAL CAPACITY FVC TEST PROCEDURE The procedures to be completed to carry out the Forced Vital Capacity FVC slow Vital Capacity VC and Maximum Voluntary Ventilation MVV tests are very similar Therefore only one detailed description will be given in this section ENTERING PATIENT PARAMETERS Start the DATOSPIR MICRO using the key wait for the main screen to appear and press the key One of the following screens will appear depending on the mode selected numeric or alphanumeric 8123466789 ICE Cod
118. nd the calibration process is completed No of Pulses number of pulses number printed on the turbine that corresponds to the number of pulses turn If the number of pulses associated to its turbine is as appears on screen continue without modifying it If it is different enter the number of turbine pulses In this case Sibelmed 7 DATOSPIR MICRO User s Manual 153 the following screen will appear o1deu5 Volume N Pulses Check that N of pulses is the same a that on the turbina Press and the factors will be calculated and the calibration process completed g ESC case of pressing the number of pulses will not change and will return to the previous screen NOTE Each turbine is factory calibrated individually and is associated to a factor equivalent to the pulses litre detected and printed on it Although dispersion among turbines is within 3 it is worth entering this factor in the spirometer if the turbine is changed to obtain the maximum measurement precision Temp ambient temperature in 9C detected by a sensor inside the equipment This can be modified if required HR relative humidity in 9o entered in the last calibration This can be modified if required Pres atmospheric pressure mmHg entered in the last calibration This can be modified if required 0 MU2 REV 2 03 Chapter 3 Models B C Operation Sibelme d DATOSPIR MICRO User s Manual 154 3 Press
119. noeuvre data selected Memory for five manoeuvres Deleting a manoeuvre Diagnosis Saving test for Post bronchial dilation Saving test on the Database Test printout e Slow Vital Capacity VC Test Similar to the FVC e Maximum Voluntary Ventilation MVV Test Similar to the FVC CALIBRATION e Calibration using a syringe e Report on the latest calibrations DATABASE Search by patient code or register number e Summarised display of the tests saved e Printing and displaying a test 511 A00 MU2 REV 2 03 2 pue g sjapow 1oe3deu Chapter 3 Models B C Operation Sibelmed DATOSPIR MICRO User s Manual 102 e Deleting a test e Summarised printing of the tests saved CUSTOMISATION e Standard Configuration Retrieving the configuration Saving the configuration Home mode customisation Patient and test data e Database customisation Number of registers e Common Customisation Setting the clock Patient code and others Numeric Alphanumeric Battery type Operating language Entering a heading in the report Selecting the printer type e Spirometry Customisation Parameters of reference and ethnic factor Observed parameters FVC VC MVV Graph selection Saving graphs on the database Printing FVC Flow Volume graph Printing FVC Volume Time graph Printing VC Volume Time graph Printing MVV Volume Time graph Diagnosis selection Comparison mode in POST bronchial dilation Weighted between PR
120. o ensure good spirometry the technician will pay particular attention to ensure that the patient has made the utmost effort that the start has been good and that no coughing or Valsava s manoeuvre due to glottis closure has occurred Special attention must be paid to preventing expiration from ending too soon which would be detected in the end of the curve which would be too perpendicular to the horizontal base line Sometimes the patient inadvertently partially obstructs the mouthpiece with his tongue or false teeth It is essential that the best two expirations from the best three acceptable curves do not vary by more than 200 ml of FVC or FEV1 The best effort cannot only be determined by merely inspecting the spirometric curve but also by checking the measurements to determine the maximum values The independent selection of FVC and FEV1 sometimes causes greater variability as factors such as learning tiredness or bronchial spasms caused by expiration come into play The best FEV1 does not have to be rejected when the manoeuvre from which it originates has ended prematurely However FEF25 759 o is influenced by the vital capacity of the curve chosen Falsely high values may be recorded if a manoeuvre with a shortened or lower vital capacity than the real vital capacity of the patient has been chosen It seems that the most practical criterion is to choose the manoeuvre containing the FVC and FEV1 with the highest sum among the three chosen fo
121. oeuvre The maximum value of the bar corresponds to a volume of 6 litres 511 A00 MU2 REV 2 03 Sibelmed 7 DATOSPIR MICRO User s Manual 49 At the end of the manoeuvre one or more of the Warnings if enabled in the Customisation Programme may appear to warn that the manoeuvre is not compliant with ATS ERS Criteria An indication is given to inform that the manoeuvre has not been carried out according to one of the following ATS ERS criteria ET Indicates that spiration has not completed satisfactorily as the variation on volume in the last second of the manoeuvre was above 25 ml or the manoeuvre has lasted less than 6 seconds in patients aged over 10 and more or less than 3 seconds in patients aged 10 or less EX Indicates that the start of expiration was not satisfactory as the extrapolated volume is above 5 of the FVC or 0 15 litres The ATS ERS recommends it be less than 5 the FVC or 0 15 litres whichever is highest The technician performing the spirometry may where considered appropriate disable these warnings in the Customisation Programme In this case they will also be removed from the printed report This disabling is only at display level The warnings are still taken into account when ordering the manoeuvres 5 Press gt key if the Warnings enabled The following screen or similar will be shown depending on the parameters selected in the Customisation Programme 511 A00 MU2 RE
122. of bronchial dilating drug established by the specialist to the patient and wait for the standardised period gt 4 Onthe main screen press the key screen similar to the following will appear which displays the tests memorised in PRE mode 511 A00 MU2 REV 2 03 Sibelmed 7 DATOSPIR MICRO User s Manual 137 PRE BRONCHIAL TESTS s ve T Using keys and the VC and MVV tests can be seen respectively saved in PRE mode Select the PRE test with which it is to be compared and press The screen then shows the two graphs PRE and POST for comparison purposes 18 15 83 24 DILAT 6 Then continue as described section 3 4 FVC TEST PROCEDURE 511 A00 MU2 REV 2 03 W 5 pue g 2 Chapter 3 Models B C Operation sibelmed DATOSPIR MICRO User s Manual 138 e In this case the curve in POST bronchial mode is compared with the curve saved in PRE bronchial mode e The data screen shows the observed values in PRE and POST mode and the method of comparison between them depending on the option selected in customisation See section 3 2 EQUIPMENT COSTUMIZATION Weighted 9o between PRE and POST 9o between REF and POST 9o between PRE and POST Difference between PRE and POST e most common method of comparison is the Weighted which corresponds to 100x2 POST
123. omagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and DATOSPIR MICRO as recommended below according to the maximum output power of the communications Separation distance according to frequency of transmitter power of transmitter m De 150 kHz a 80 MHz De 80 MHz a 800 MHz 800 MHz to 2 5 GHz w 4 3 3 3 0 01 0 12 0 12 0 23 0 1 0 37 0 37 0 74 1 1 17 1 17 2 33 10 3 69 3 69 7 38 100 11 67 11 67 23 33 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer Note 1 At 800 MHz the separation distance for the higher frequency applies Note 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absortion and reflection from structures objects and people 511 A00 MU2 REV 2 03 I xipueddy Appendix 1 Electromagnetic Compatibility Sibelmed DATOSPIR MICRO User s Manual 232 511 A00 MU2 REV 2 03 5 7 DATOSPIR MICRO User s Manual 233 SSS APPENDIX 2 COMPLIANCE WITH THE DATA PROTECTION ACT LOPD 511 00 02
124. ong with the model the 511 A00 MU2 REV 2 03 y 4 Chapter 2 Model A Operating 5 7 DATOSPIR MICRO User s Manual 96 programme version and the bios version programme run during booting the date and the time e Ifstart up is automatic because it is the time programmed in Alarms 1 The equipment will start up and the start screen will appear along with the model the programme version and the bios version the date and the time The following screen will then appear START THE TEST PRESS THE KEY and the equipment will issue a beeping sound every 10 seconds If for 2 minutes gt is not pressed the equipment will switch off Press the key b 2 following screen will appear BLOW The patient is given 30 seconds to start the FORCED EXPIRATION manoeuvre following screen is then displayed BLOW AGAIN 511 A00 MU2 REV 2 03 Sibelmed 7 DATOSPIR MICRO User s Manual 4 The patient has to perform three expiratory manoeuvres After the three manoeuvres an arrow will appear to indicate the semaphore zone in question GREEN YELLOW or RED in line with the programme produced by the specialist The equipment automatically saves the best manoeuvre to memory according to the following criteria e The one with the best sum of FVC is considered the best e The one with the best FVC is considered the best
125. or who sold you the product 511 A00 MU2 REV 2 03 Safety Sibe med DATOSPIR MICRO User s Manual 511 A00 MU2 REV 2 03 S belmed DATOSPIR MICRO User s Manual 17 1 INSTRUCTIONS FOR USE AND INSTALLATION 511 A00 MU2 REV 2 03 pue esf 40 Suoinajsug Chapter 1 Instructions for Use and Installation Sibelmed DATOSPIR MICRO User s Manual 18 1 1 INTRODUCTION The DATOSPIR MICRO spirometer is a compact device with a 2x16 screen Model A or a high resolution graphic touch screen Models B and C depending on the model It works with turbine type transducers that can be connected to an external printer by USB It can incorporate a module for pulse oximetry measurements SpO Furthermore using software included depending on the model it can be connected in real or deferred time to a PC for spirometric tests with PC support to save completed tests or to transfer data via other means It can be connected to the PC using an RS 232 cable a Mini USB cable included as standard or by Bluetooth optional The entire system is controlled by a microprocessor for the acquisition calculation and presentation of alphanumeric and graphical data The DATOSPIR MICRO is available in a series of models depending on the different options included as indicated in detail below 511 00 02 REV 2 03 Sibelmed 7 DATOSPIR MICRO User s Manual 19
126. orated based on a volume signal of reference e g a syringe Furthermore this calibration factor must take the changes in volume associated to atmospheric conditions into account The most influential factor is temperature The DATOSPIR MICRO includes a Calibration Programme for fast less than one minute and easy checking and auto correcting of diversion in the measurements taken based on a standard or reference volume for the quality control of the different spirometric tests The regularity of calibration depends on the user although normative recommends it be done on a daily or weekly basis CALIBRATION PROCESS The calibration process is as follows 1 Install the spirometer and the syringe as in the figure 511 A00 MU2 REV 2 03 Sibelmed 7 DATOSPIR MICRO User s Manual 71 JERINGA DE CALIBRAC ION 2 Start the DATOSPIR MICRO using the key and wait for the following screen to appear MAIN MENU 1 Spirometry With the keys v select MAIN MENU 2 Calibration 4 Press the following screen will appear CALIBRATION 1 Calibration 511 A00 MU2 REV 2 03 y 4 Chapter 2 Model Operating Sibelmed 7 DATOSPIR MICRO User s Manual 72 5 Press gt enter the volume of the syringe in litres between 0 and 6 litres depending on the syringe CAL DATA Volume 1 x If a 0 is entered the default factors are used Fct 1 and NPu
127. pear when it is started ENTER PIN Pin 0000 Enter PIN If the PIN configured in Equipment protection customisation is entered access will be given to the DATOSPIR MICRO and the main screen will appear If an erroneous PIN is entered three times the equipment will lock and will switch off The following screen will appear when it is restarted UNLOCK CODE 00000000000000 Enter the unlock code PUK supplied on purchasing the equipment If the correct code is entered the DATOSPIR MICRO will unlock and the main screen will appear From then on the equipment will return to its initial status Protection disabled and PIN 0000 If an erroneous code is entered the equipment will remain locked This prevents access to the equipment and more specifically to the private data it contains by unauthorised people 511 A00 MU2 REV 2 03 Sibelmed 7 DATOSPIR MICRO User s Manual 43 2 4 FORCED VITAL CAPACITY FVC TEST PROCEDURE The procedures to be completed to carry out the Forced Vital Capacity FVC slow Vital Capacity VC and Maximum Voluntary Ventilation tests are very similar Therefore only one detailed description will be given in this section ENTERING PATIENT PARAMETERS Start the DATOSPIR MICRO using the key and wait for the following screen to appear MAIN MENU 1 Spirometry Press the gt key and the following will appear SPIROMETRY 1 FVC Press the gt key and the following will a
128. ppear PATIENT DETAILS Code 0000000000 Enter the patient code between 0 and 9999999999 511 A00 MU2 e REV 2 03 4 Chapter 2 Model Operating Sibelmed 7 DATOSPIR MICRO User s Manual 44 Select the digits using the keys gt set the value for each digit key to go to the next and so on g Press the in the remaining screens indicated PATIENT DETAILS Age years Between 4 and 100 PATIENT DETAILS Height cm Between 50 and 230 cm PATIENT DETAILS Weight Kg xx Between 15 and 200 Kg PATIENT DETAILS Sex Man Between male and female PATIENT DETAILS I Smoker xx Between 0 and 200 packs a day per number of years PATIENT DETAILS Cig day xx Between 0 and 20 cigarettes PATIENT DETAILS Ethnic F XXX Between 80 and 120 The Smoker Index is the same as the number of cigarettes smoked a day divided by 20 and multiplied by the number of years smoking cigarettes day x years smoking 20 511 A00 MU2 REV 2 03 Sibelmed 7 DATOSPIR MICRO User s Manual 45 The ethnic factor is used in areas without any parameters of reference that use some existing yet corrected in a certain percentage This factor MUST BE SET TO 100 IF NOT USED and can only be modified through the Customisation Programme Press the gt key to go to the FVC TEST screen Use the or keys to select one of the following options
129. programme will be transmitted The process may take around 10 minutes depending on the PC 9 Switch off the DATOSPIR MICRO 511 A00 MU2 REV 2 03 uonesdo 2 pue sjapow 193deu Chapter 3 Models C Operation Sibelmed DATOSPIR MICRO User s Manual 174 3 13 HOME MODE OPERATION The DATOSPIR MICRO spirometer is very useful for monitoring and controlling asthmatic patients or others to suit the specialist s criteria whether they are at home or in hospital With this option the spirometer is extremely user friendly equipment as the sequence of instructions on screen will guide patients during spirometric manoeuvres At the same time it automatically saves the best manoeuvres made in the different tests in the memory This enables the specialist to subsequently analyse them and make the corresponding diagnosis It is also possible to transfer them from the equipment Database to the PC Database using W20 Spirometry Software Three stages can be described for a better understanding of this operating mode 1 Spirometer configuration 2 Acquisition of spirometric tests 3 Displaying of the information saved CONFIGURATION The specialist must configure the spirometer in HOME mode and provide the patient with the necessary instructions The process to follow is as described below From the main screen press and then press 511 00 02 REV 2 03 Sibelmed 7 DATOSPIR MICRO User s Manual 175 Ho
130. r calculation 7 2 CALIBRATIONS As well as the calibration procedures included by the manufacturer in the appliance to quickly check the working order of the basic pneumotachometer circuits and mechanisms it must be possible to check the appliance through external signals These signals must be as similar as possible in terms of flows volumes and times to the biological signal for which the instruments were designed i e forced expiration This is not always possible 4 Anawods nb uy 9 Sibelmed DATOSPIR MICRO User s Manual 216 9 although at least one of the elements of the biological signal the volume or the flow must be reproduced together or separately c Along these lines the syringes holding several litres provide a suitable signal and the flow generators be used assess the precision and errors in flow measurement Among the most suitable calibration appliances is the so called explosive decompressor which consists of a 4 or 5 litre pressurised 0 atmosphere chamber fitted with fast opening for the sudden 2 expulsion of an identical volume to that of the chamber This simulates the forced expiration of a person and with suitable resistances at different levels of obstruction fitted to the output tube the signal is similar to that of a patient with slight moderate or severe obstruction in the air flow Hence the volume 5 flow measurement exam
131. rameters selected in the Customisation Programme If an appears after the REF test this means that the values of reference have been extrapolated e It also displays 511 A00 MU2 REV 2 03 Sibelmed 7 DATOSPIR MICRO User s Manual 123 The best FVC and FEV1 values that may correspond to different manoeuvres Ethnic factor if not used this must be 100 Warnings of Non Compliance with ATS ERS criteria for each manoeuvre WARNING As indicated the BEST manoeuvre is set at M1 Therefore use M1 to display the diagnosis to print the report or to save the manoeuvre for the POST bronchial dilation or for the Internal Database except where the user considers it wise to choose a different one TYPE OF DIAGNOSIS The DATOSPIR MICRO spirometer has two types of diagnosis that can be selected in the Customisation Programme NOTE If you do not agree with these two criteria do not use them as a reference The diagnosis and the results of the test must always be validated by the specialist e Miller Diagnosis This presents the following information NORMAL RESTRICTIVE OBSTRUCTIVE or COMBINED according to the criteria of the following chart 511 A00 MU2 REV 2 03 2 pue sjapow Chapter 3 Models C Operation Sibelmed DATOSPIR MICRO User s Manual 124 MILLER QUADRANT 28 T Restrictive i Normal 19a e Snider Kory amp Lyons Diagno
132. re similar to the FVC VC and MVV procedures With these curves you can operate the equipment as if they were real patient curves with slight exceptions 511 A00 MU2 REV 2 03 5 7 DATOSPIR MICRO User s Manual 169 EQUIPMENT CONFIGURATION Select the option to configure different options of the equipment CONFIG EULIP 18 51 mmm UPDATE KEY 21975 15511 88476 Positive Expiration REINO Go back to the previous screen ESC Reset all equipment variables Reindex the database Change from positive VC to negative VC and vice versa e An updating key is also displayed which is necessary for updating the equipment and obtaining a new improved version of it 511 A00 MU2 REV 2 03 2 pue g sjapow 1o3deu Chapter 3 Models C Operation Sibelmed DATOSPIR MICRO User s Manual 170 3 12 UPDATING INTERNAL SOFTWARE The DATOSPIR MICRO spirometer has two types of internal software e Bios basic hardware control programme e Flash programme containing all the equipment options The update option allows for the version of Bios and or Flash to be updated without having to take the equipment to the factory and without having to open it WARNING Both updates are completed through the serial port RS232 BIOS UPDATE The updating process for the BIOS programme is as follows 1 Run the W 20 Spirometry Soft
133. rom their compartment before cleaning PULSE OXIMETRY FINGER CLIP Although unlikely the organisms can also be transmitted by pulse oximetry Therefore the pulse oximeter finger clip should be washed with each patient change using either soapy water or a glutaraldehyde solution Instrunet type 511 A00 MU2 REV 2 03 9A172910 pue deexdp 8 1o3deu Chapter 8 Upkeep Preventative and Corrective Maintenance Sibelmed 7 DATOSPIR MICRO User s Manual 224 8 2 PREVENTATIVE MAINTENANCE Preventative maintenance consists of any actions aimed at keeping the equipment in a good state of repair Four types of preventative maintenance are established 1 Every time it is started the equipment will check certain parts 2 Asecond type which be performed by the user consists of the regular monitoring of the appearance of the different connections and other external parts of the equipment Check that all connections are perfectly connected that no cable and or connector or any other element is broken or damaged In the event of detecting any problem that the user cannot solve contact the SIBEL S A After Sales Service or your distributor to review or repair it user access the Maintenance Programme to adjust and or check any parts of the equipment as indicated in detail in the corresponding section 4 fourth type consists of a general technical check o
134. s name This can be omitted if you wish Sur Surnames 25 character alphanumeric field corresponding to the patient s surnames This can be omitted if you wish In alphanumeric fields Forename Surname Code etc a double click on the field can fully delete it T Enter the patient s details and press the key to go to the test screen 511 A00 MU2 REV 2 03 2 pue sjapow Chapter 3 Models C Operation Sibelmed DATOSPIR MICRO User s Manual 116 ENTERING FORCED VITAL CAPACITY TESTS Go back to the previous screen Start the manoeuvre Save the manoeuvre the database Modify the patient s details Next view the second group of buttons Back view the first group of buttons Delete the manoeuvre Display the manoeuvre diagnosis Ew TES Print the manoeuvre report Mir There are other areas of the screen that also have certain functions e Pressingonthe axes changes the type of graph Flow Volume or Volume Time e Pressing on the parameters displays the screen containing 511 A00 MU2 REV 2 03 Sibelmed 7 DATOSPIR MICRO User s Manual 117 the data on the selected manoeuvre e Pressing on a manoeuvre selects it This allows you to see its graph consult its parameters or print a report e Pressing on the graph area makes the buttons disappear and makes it larger or smaller 1 16 24 83
135. ser s Manual 203 e EN 62366 2008 Application of engineering skills to use medical devices VIBRATION AND TEMPERATURE e Series EN 60721 1995 Classification of environmental conditions e Series EN 60068 1999 Environmental testing BIOCOMPATIBILITY e ISO 10993 1 2009 Biological evaluation of medical devices Part 1 SOFTWARE e EN 62304 2006 Software for Medical Devices DOCUMENTATION AND INFORMATION e EN 1041 2008 and EN 980 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 BLUETOOTH MODULE e Compliance with Standard 2 0 e Class II CEand FCC Certificate 2 Related to the manufacturer QUALITY e EN ISO 13485 2012 Quality management systems Requirements for regulatory purposes EN ISO 9001 2008 quality management Requirements ENISO 14971 2012 Risk management in medical equipment 511 A00 MU2 REV 2 03 suoneoyi2eds 6 193deu Chapter 5 Technical Specifications Sibelmed 7 DATOSPIR MICRO User s Manual 204 WASTE e RD 208 2005 Electrical and electronic equipment and waste management Transposition of WEEE 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 WEEE 2002 96 CE Directive 511 A00 MU2 REV
136. sis This is based on the following criteria If FVC gt 80 of the FVC Reference and FEV1 gt 80 of the FEV1 Reference Values in the range of reference Normal Diagnosis If FEV1 FVC lt FEV1 FVC Reference FEV1 lt 80 of the FEV1 Reference Obstructive ventilatory defect FEV1 lt 80 Slight FEV1 lt 65 Moderate FEV1 lt 509 Intense FEV1 359 o Very Intense If FEV1 FVC lt FEV1 FVC Reference and FVC 80 of the FVC Reference Non obstructive ventilatory defect lt 80 Slight lt 65 Moderate lt 50 Intense lt 35 Very Intense If FEV1 FVC lt FEV1 FVC Reference and FVC gt 80 of the FVC Reference Mixed ventilatory defect is suspected 511 A00 MU2 REV 2 03 Sibelmed 7 DATOSPIR MICRO User s Manual 125 If FEV1 FVC lt FEV1 FVC Reference and FEV1 gt 80 of the FEV1 Reference Mixed ventilatory defect is suspected If the POST bronchial dilation test is carried out and the FEV1 POST exceeds the base FEV1 or PRE by 15 There is a positive response to the bronchial dilating drug To see the diagnosis of the selected manoeuvre press the key One of the following screens will appear depending on the customised diagnosis DIAGNOSIS ACC SNIDER KORY amp LYONS Restrict iNorm H Walues within reference marvin Normal mom KORY Combined i bst ESC 20 6 0 120
137. ss the Maintenance options Using keys and v you can move around the different options to 1 Configure the calibration and or maintenance warnings 2 Adjust the screen contrast 3 Auto check the equipment 4 Configure the equipment 5 Check with pre saved standard curves WARNINGS Select the option MAINTENANCE 1 Select Warning 511 A00 MU2 REV 2 03 Sibelmed 7 DATOSPIR MICRO User s Manual 81 This option indicates the tests completed and allows for the periods in days between calibrations or between preventative maintenance work on the equipment to be defined If the days specified without calibration or maintenance are exceeded the equipment warns of such by displaying a sign every time it is started If O days is entered a warning is never given Press gt and the next screen will appear to enter the calibration period Calibration Period x Press gt and the next screen will appear to enter the maintenance period Maintenance Period XXX Press gt and an informative screen will appear with the date of the last maintenance work Press gt and an informative screen will appear with the total number of tests completed Press gt an informative screen will appear with the number of tests completed since the last maintenance work 511 A00 MU2 REV 2 03 y 4 Chapter 2 Model A Operating Sibelmed 7 DATOSPIR MICRO User s M
138. ssories and spare parts etc must be originals and are to be requested from the manufacturer or authorised distributor in order to ensure the correct working order of the spirometer MANUFACTURER S LIABILITY SIBEL S A is only liable for the safety reliability and working order of this equipment if e place where the equipment is installed or used is compliant with the requirements related to the IEC electrical installation and other applicable regulations e Allrepairs services and modifications inside and outside the guarantee period are carried out by SIBEL S A technical staff e equipment is used by skilled staff according to the recommendations of this User Manual Chapter 1 Instructions for Use and Installation S belmed 7 DATOSPIR MICRO User s Manual 24 1 4 LAYOUT OF CONTROLS PILOT LIGHTS AND CONNECTORS MODELA 1 On off button 2 Alphanumeric LCD display 3 Keypad 4 Turbine transducer 5 USB connection 6 RS 232 series connection 7 Specifications plate 8 Lithium battery CR1632 9 Firmware loading switch 10 Main batteries 2xAA 1 5V 511 00 02 REV 2 03 Sibelmed 7 DATOSPIR MICRO User s Manual 25 1 On off button 2 Graphic LCD display 3 Turbine transducer 4 USB connection 5 RS 232 series connection SpO Connection 6 Specifications plate 7 Lithium battery CR1632 8 Firmware loading switch 9 Main batteries 2xAA 1 5V 511 A00 M
139. ters will be calculated on the total memory If you want to perform the test on another patient you must delete the test by pressing and change the patient s details by pressing Wl To calculate the parameters press If the finger clip is disconnected the periods in which the SpO PR value is 0 will not be taken into account when calculating the parameters and the length of the test CONFIGURATION While the oximetry signals are being acquired it is possible to access the average SpO and beeping sound signal coinciding with each pulse configuration menu Press and you will access the same screen indicated in the PULSE OXIMETRY CUSTOMISATION section to modify these two parameters 511 A00 MU2 REV 2 03 2 pue Chapter 3 Models C Operation DATOSPIR MICRO User s Manual 146 DISPLAYING TRENDS You can only access the trends menu if the study has been saved Press 0123456739 17 53 03706 PULSE OAM EF 0123456789 17 54 0306 PULSE 00 00 45 00 00 40 00 00 45 ESC Exits this screen and goes back to the previous one 4 and gt Goes back or forwards one page Locates the next crossing point with the reference line Displays the other buttons 2 Configures the trends screen Calculates and displays the value of the parameters The screen displays the fragment of the SpO an
140. tes the percentage of the report produced Printing can be cancelled at any time by pressing the lt key DELETING A MANOEUVRE MADE The DATOSPIR MICRO spirometer deletes any manoeuvre made whether it is because you are doubtful as to whether its values are correct due to a defective performance which may distort the results or because of any other reason The process is similar to that described in the previous section but previously selecting the option 511 A00 MU2 e REV 2 03 epow 4 Chapter 2 Model A Operating 5 7 DATOSPIR MICRO User s Manual 60 FVC TEST 7 Delete Press the gt key and a similar screen to the following will appear DELETE M1 M2 Select the manoeuvre to delete flashing and press gt The following screen will appear WANT TO DELETE THE MANOEUVRE Press the 4 key to cancel and not delete the manoeuvre If you press the gt key to delete the manoeuvre the following screen will appear MANOEUVRE N X DELETED OTHER TESTS ON THE SAME PATIENT You can do the following after carrying out the FVC test on a patient 511 A00 MU2 REV 2 03 Sibelmed 7 DATOSPIR MICRO User s Manual A VC on the same patient An MVV test on the same patient A Post bronchial dilation test on the same patient Print the general report of all tests on the same patient Start the test process on another patient The spirometer sav
141. tors Patients to have suffered myocardial infarction during the past month are recommended not to take the test In patients with thoracic or abdominal pain oral or facial injuries stress or dementia of any kind the results may not be optimal and repeatable 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 DEGREE OF PROTECTION AGAINST LIQUIDS Degree of protection against harmful ingress of water Drip proof IPX1 511 A00 MU2 REV 2 03 Sibelmed DATOSPIR MICRO User s Manual 13 ELECTRICAL RISKS Dot NOT remove the equipment casing The device must only be serviced and repaired by skilled personnel The contact with voltage inside the system may cause serious injury Do NOT use damaged accessories Do NOT submerge the parts of the device in any liquid THIS MAY CAUSE ELECTRIC SHOCKS Consult the equipment cleaning method in Chapter 8 Section 8 1 UPKEEP PREVENTATIVE AND CORRECTIVE MAINTENANCE ELECTRICAL SHOCK To ensure vital safety features under the EN 60601 1 1 standard only equipment compliant with the electrical safety standards in force may be connected to this device To connect Datospir Mi
142. ture differentiating Model A from Models B and C is its operating mode Model works with a 2 line screen in text mode and using 4 silicon keys Models B and C work with a touch screen in graphic mode and using a pointer 511 00 02 REV 2 03 S belmed DATOSPIR MICRO User s Manual RELACI N DE CONTENIDO PACKING LIST P gina 1 de 2 DATOSPIR MICRO 511 A08 010 REV 9 2013 06 MODELOS MODELS CODIGO CANT DESCRIPCI N A B C CODE QTY DESCRIPTION 1 DATOSPIR MICRO MODELO MODEL SN 11A 04194 1 C DIGO DESBLOQUEO PUK PERSONAL UNBLOCKING KEY PUK 02755 1 PUNTERO POINTER s 01555 50 BOQUILLA CART N DESECHABLE DISPOSABLE MOUTHPIECE 07101 1 100 BOQUILLA CART N DESECHABLE ENVASADA INDIVIDUALMENTE DISPOSABLE MOUTHPIECEINDIV PACKED 01569 1 BOQUILLA DE PLASTICO PLASTIC MOUTHPIECE 02692 1 PINZA NASAL NOSE CLIP 1 GUIA RAPIDA DE USO MOD A CASTELLANO Doc 511 A11 GR1 asie fice ENGLISH MOD A QUICK REFERENCE Doc 511 A11 GR2 1 GUIA RAPIDA DE USO MOD B C CASTELLANO Doc 511 A21 GR1 ENGLISH MOD B C QUICK REFERENCE Doc 511 A21 GR2 01683 1 CONEXI N PC USB USB PC CONNECTION LINK CABLE MINI USB B 5 PINES USB A 03673 2 PILA AA 1 5V ALCALINA AA 1 5V ALKALINE BATTERY 03175 1 TRANSDUCTOR TURBINA TURBINE TRANSDUCER 07426 1 MALETA DE TRANSPORTE CARRYING CASE 01811 1 CONEXI N PC RS232 PC RS232 CONNECTION
143. ual 177 The alarms are a reminder for the patient as the test can be taken at any time despite it being different to the time programmed and the time it is taken is recorded DAILY TESTS Mo Tests Select the days of the week on which the tests are to be performed TEST DAYS Wednesday Thursday Friday Saturday Sund as Chapter 3 Models C Operation Sibelmed DATOSPIR MICRO User s Manual 178 Home mode is now configured so that you simply have to press Fe on the main screen to enable it and to switch off the equipment ACQUISITION OF SPIROMETRIC TESTS Once the equipment has been configured by the specialist the test acquisition process can begin The storage capacity is 150 or 1000 tests depending on the database or H The specialist will explain the test to the patient particularly the forced expiration manoeuvre process the equipment operating sequence and when the tests should be taken The operating sequence is as follows If start up is manual the patient starts the equipment 1 start screen will appear along with the model the programme version and the bios version the date and the time If start up is automatic because it is the time programmed in Alarms 1 equipment will start up and the start screen will appear along with the model the programme version and the bios version the date and the time The following screen will then
144. ueddy 13 0 132 3 Electromagnetic Compatibility Appendix 1 Sibelmed 7 DATOSPIR MICRO User s Manual 230 Guidance and manufacturer s declaration electromagnetic immunity DATOSPIR MICRO is intended for use in the electromagnetic environment specified below The costumer or the user of DATOSPIR MICRO should assure that it is used in such an environment Immunity test Conducted RF EN IEC 61000 4 6 Radiated RF EN IEC 61000 4 3 EN IEC 60601 test level 3 Vrms 150KHz to 80 MHz 3 V m 80 MHz to 2 5 GHz Compliance level 3 Vrms 3 Vim Electromagnetic environment guidance Portable and mobile RF communications equipment should be used no closer to any part of DATOSPIR MICRO including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance gt 80 MHz to 800 MHz fa P 80 MHz to 800 MHz d P 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 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 2 Interference occur in the vicinity of equipment marked wit
145. ulting parameter printing a report etc 511 A00 MU2 REV 2 03 2 pue sjapow 1oe3deu Chapter 3 Models and C Operation Sibelmed DATOSPIR MICRO User s Manual 184 511 A00 MU2 REV 2 03 Sibelmed DATOSPIR MICRO User s Manual 185 4 COMMUNICATIONS SYSTEM 511 A00 MU2 REV 2 03 15 5 suome2iunuiuio Chapter 4 Communications system Sibelmed 7 DATOSPIR MICRO User s Manual 186 One of the great qualities of the DATOSPIR MICRO is its Communications System with other means that enable it to Transfer Equipment Checking Data Updating Internal Software Transfer Tests on patients to a PC Export Tests on patients to other Management Systems Communications can be made through three different channels using the corresponding software e RS232C Series standard e USB standard e Bluetooth optional To install USB and Bluetooth consult the W20 Spirometry Software User s Manual 4 1 TRANSFERRING EQUIPMENT CHEQUE DATA AND DATABASE DATA The DATOSPIR MICRO includes a programme that auto checks the working order of certain parts of the equipment displaying the information on the screen and saving it in an internal file The information available is Hardware check Software check Equipment customisation Calibration Registering FVC test with standard curve If a problem is detected that the user is unable to solve the first alternative is to sen
146. urbine e Measurement Scale BTPS Flow 1 5 Oto 16 Volume 1 O to 10 e Dynamic flow resistance kPa l s lt 0 122 to 14 1 5 e Precision of measurements BTPS Volume the highest 3 or 50 ml Flow the highest 5 or 150 ml s Time related precision 0 5 e Resolution volume ml lt 6 e Sampling frequency Hz 25 e Turbine lifetime 600 disinfections or 3 years SpO and Pulse Measurement Range Resolution Precision 70 to 100 the highest 70 SpO 90 Pulse BPM 0 100 0 250 1 1 2 1 3 Not specified 511 A00 MU2 REV 2 03 Sibelmed 7 DATOSPIR MICRO User s Manual 199 5 3 MICRO CONTROLLER System micro controller e Hitachi H8S2144 Volume accumulation time e Five FVC curves with a maximum of 25 seconds each e Five VC curves with a maximum of 45 seconds each e Five MVV curves with a maximum of 15 seconds each Start FVC expiration e Using the retrograde extrapolation method End FVC expiration When the volume accumulated in the last second is below 0 025 litres FVC test selection e According to the criterion of the maximum sum of FVC FEV1 or depending on the operator Parameter selection FVC FEV1 the two with the highest value of the tests saved Remaining parameters of the selected test with the highest sum being recommended Keypad e Allinstructions data etc transmitted by the operator to the microprocessor involve a keypad with sili
147. utor details E H 4 m Pulse oximetry module Check the external printer selected The SIBELMED logo the heading lines and 10 lines of characters will be printed Mur Check that the automatic on and off work properly Upon selecting this option the equipment switches off and on automatically after 5 seconds 5 Display the values of different variables No pulses Turbine Fct Alk B Li B etc This indicates whether the read value is correct gt a o v Dewi Ho of Pulses Turbine Factor Vari ables d 4 Y Alkaline Bat Lithium Bat ESC Temrerature CPU CPU check This calculates the Flash programme checksum and the Bios programme checksum It also indicates whether there are errors in the RAM memory of the CPU and in the external RAM 511 00 02 e REV 2 03 2 pue sjapow 1oe3deu Chapter 3 Models C Operation sibelmed DATOSPIR MICRO User s Manual 168 CHECKING aueF aaa Flash Checksum Bios Checksum x4650 Dewi ce Errors CPU External LCD Performs a test on the LCD Follow the instructions given on the screen Touch Screen STANDARD CURVES Select the A option to check the working order of the equipment through certain pre saved curves ean z rl STAND CURVES 18 51 mm ESC MV Select the curve type and follow the instructions on the screen which a
148. ving modified some details of an existing patient his parameters will be recalculated taking the changes made into account 511 A00 MU2 REV 2 03 S be med 7 DATOSPIR MICRO User s Manual 2 5 SLOW VITAL CAPACITY VC TEST PROCEDURE The procedure to carry out the slow Vital Capacity VC test is similar to that described in Section 2 4 FORCED VITAL CAPACITY PROCEDURE with the following variations 1 Ifthe test is carried out the same patient as described in the OTHER TESTS ON THE SAME PATIENT section go back using the key to the Test Selection window and select using keys or v the VC test SPIROMETRY 2 VC If the patient is new begin as described in the ENTERING PATIENT PARAMETERS section 2 Instruct the patient as to how to carry out this type of test as his cooperation is vital for it to be completed correctly maximum time allowed for the manoeuvre is 45 seconds The equipment saves a maximum of five manoeuvres ordered according to the VC value where M1 is the best VC and M3 the worst 4 To measure the ERV and TV parameters correctly each manoeuvre must have at least four respiratory cycles 5 The register of parameters and graphics is as shown below 511 00 02 e REV 2 03 y 4 ing Model A Operat Chapter 2 5 7 DATOSPIR MICRO User s Manual Sibelmed DATOSPIR MICRO SIBEL S A
149. ware and access the Configuration Hardware Test option Run a communications test to check that the connections are correct 2 Switch the equipment off With the DATOSPIR MICRO switched off remove the rear cover disconnect the Bluetooth where applicable and turn both switches ON 511 A00 MU2 REV 2 03 Sibelmed 7 DATOSPIR MICRO User s Manual 171 WARNING This option should be carried out by an expert or specialist 4 Turn the equipment and support it on the table with the screen visible 5 Press the On Off key for 1 second and release it Nothing will appear on the screen 6 Copy the Bios file DMBios tsk into the FIRMWARE directory of the application W20 7 Run the W 20 Spirometry Software access the Configuration Links option and check that the DATOSPIR MICRO is selected 8 Access the Configuration Utilities Update Bios option 9 Follow the instructions on screen and wait for the process to end 10 Once completed turn both updating switches OFF again replace the Bluetooth where applicable and close the cover FLASH UPDATE Flash can be updated for a new version of the programme in which improvements have been included or to add another option to the equipment dilation option Bluetooth etc In the case of the latter SIBEL S A will provide a new update key 511 A00 MU2 REV 2 03 2 pue sjapow 1oe3deu Chapter 3 Models B C Operation S
150. x 8 Press gt The relative humidity 96 entered the last calibration will appear This can be modified if required CAL DATA Humidity 96 xx 9 Press b The atmospheric pressure mmHg entered in the last calibration will appear This can be modified if required 511 A00 MU2 REV 2 03 y 4 Chapter 2 Model A Operating S belmed DATOSPIR MICRO User s Manual 74 CAL DATA Pres mmHg xxx 10 Press gt the following screen will appear CALIBRATION Start Calibra 11 Press gt again and start emptying the syringe for two or more consecutive cycles one cycle is equal to emptying and filling the syringe When emptying and filling the syringe piston must move all the volume used as a reference If this is not done correctly the equipment will detect it as incorrect manoeuvres Furthermore this process should be completed in a regular and uniform manner without causing flow rates that are too high or too low Where this is not the case you will be told to repeat the manoeuvre The time of each cycle emptying plus filling the syringe most be no less than four seconds and no more than ten The equipment waits for 30 seconds for calibration to begin The process must be restarted if this time is exceeded During calibration the second line of the screen will show a bar movement of which is proportional to the volumen applied On completion
151. y and fitting the nose clip 511 A00 MU2 REV 2 03 Sibelmed 7 DATOSPIR MICRO User s Manual 119 1 4 Press the key and wait until a flashing arrow appears on the screen Then start the spirometric manoeuvre The manoeuvre underway can be ended at any time by pressing ESC the key The equipment is held so that the doctor can see the screen while the patient is carrying out the tests indicates the current manoeuvre indicates the selected manoeuvre the best is selected by default M1 511 A00 MU2 REV 2 03 2 pue sjapow 1oe3deu Sibelmed DATOSPIR MICRO User s Manual 120 At the end of the manoeuvre one or more of the Warnings if enabled in the Customisation Programme may appear to warn whether the manoeuvre is compliant with ATS ERS Criteria According to the indication the manoeuvre has not been carried out according to one of the following ATS ERS criteria ET Indicates that spiration has not completed satisfactorily as the variation on volume in the last second of the manoeuvre was above 25 ml or the manoeuvre has lasted less than 6 seconds in patients aged over 10 and more or less than 3 seconds e 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 0 15 litres 5 ATS ERS recommends it be less than 5 of the FVC or 0

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