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Sibelmed DATOSPIR MICRO A User Manual

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DATOSPIR MICRO
SPIROMETER
USER MANUAL
511-A00-MU2 • REV. 2.06 • 2019-03

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  • Page 1 DATOSPIR MICRO SPIROMETER USER MANUAL 511-A00-MU2 • REV. 2.06 • 2019-03...
  • Page 2 DATOSPIR MICRO User’s Manual SIBEL S.A.U., Rosellón 500 bajos, 08026 BARCELONA (Spain) National Sales: Tel. 93 436 00 08 e-mail: comercial@sibelmed.com International Sales:Tel. +34 93 436 00 07 e-mail: export@sibelmed.com Technical service: Tel. +34 93 433 54 50 e-mail: sat@sibelmed.com...
  • Page 3 DATOSPIR MICRO User’s Manual INDEX SAFETY .............. 9 1.1 INTRODUCTION ..........16 1.2 PRELIMINARY OBSERVATIONS ......17 1.3 DATOSPIR MICRO SPIROMETER MODELS ..18 1.4 LAYOUT OF CONTROLS, PILOT LIGHTS AND CONNECTORS ............ 22 1.5 INSTALLATION AND START-UP ......24 1.6 OPERATING MODES ........
  • Page 4 DATOSPIR MICRO User’s Manual 3.8 CALIBRATION PROCEDURE ......138 3.9 INTERNAL DATABASE ........144 3.10 MAINTENANCE PROGRAMME ....... 151 3.11 UPDATING INTERNAL SOFTWARE ....157 3.12 PATIENT MODE OPERATION ......161 4. COMMUNICATIONS ........171 4.1 TRANSFERRING EQUIPMENT CHEQUE DATA AND DATABASE DATA ..........
  • Page 5 DATOSPIR MICRO User’s Manual 8.2 PREVENTATIVE MAINTENANCE ...... 210 8.3 CORRECTIVE MAINTENANCE ......211 APPENDIX 1 ............. 213 ELECTROMAGNETIC ........213 COMPATIBILITY ..........213 APPENDIX 2 ..........219 511-A00-MU2 • REV. 2.06...
  • Page 6 DATOSPIR MICRO User’s Manual 511-A00-MU2 • REV. 2.06...
  • Page 7 DATOSPIR MICRO User’s Manual The DATOSPIR MICRO Spirometer has been designed by the SIBEL, S.A.U. R&D&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...
  • Page 8 DATOSPIR MICRO User’s Manual 511-A00-MU2 • REV. 2.06...

  • Page 9: Special Precautions

    DATOSPIR MICRO User’s Manual SAFETY SPECIAL PRECAUTIONS The DATOSPIR MICRO spirometer has been designed for use with the utmost safety. All operating instructions must be read before using the DATOSPIR MICRO. Not doing so may lead to injuries to the user or the patient and damage to equipment and/ or accessories.

  • Page 10: Limitations Of Use. Contraindications

    DATOSPIR MICRO User’s Manual The spirometer is designed to be used by medical staff only, being supervised by a physician. Specific training 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.

  • Page 11: Electrical Risks

    DATOSPIR MICRO User’s Manual Acceptability of a test is the responsibility of the medical staff. The spirometer must not be used when the validity of the results is likely to be jeopardised by external factors. Patients to have suffered myocardial infarction during the past month are recommended not to take the test.

  • Page 12: Electrical Shock

    DATOSPIR MICRO User’s Manual comply with the specified accuracy and / or indicate whether the maneuver is correct), the presentation of results and the storage and integrity of the data in memory are considered to be essential operations. Communication with the computer is not considered essential as long as the integrity of the data is guaranteed.
  • Page 13 DATOSPIR MICRO User’s Manual can generate interferences (radios, cellular phones, etc.) should be kept apart. The portable or mobile radiofrequency devices can affect the normal functioning of the electronic medical devices. This is a medical electronic device and as such it needs special precautions regarding the electromagnetic compatibility (EMC) and it should be installed and setup according to the EMC information attached (See Appendix 1.
  • Page 14 DATOSPIR MICRO User’s Manual 511-A00-MU2 • REV. 2.06...
  • Page 15 DATOSPIR MICRO User’s Manual . INSTRUCTIONS FOR USE AND INSTALLATION 511-A00-MU2 • REV. 2.06...
  • Page 16 DATOSPIR MICRO User’s Manual 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.

  • Page 17: Preliminary Observations

    DATOSPIR MICRO User’s Manual 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.
  • Page 18 1.3 DATOSPIR MICRO SPIROMETER MODELS The DATOSPIR MICRO spirometer series is made up of the following models, depending on the options included: DATOSPIR MICRO A DATOSPIR MICRO B DATOSPIR MICRO C The enclosed tables show the basic standard features of each model and all other optional parts and functions.
  • Page 19 DATOSPIR MICRO User’s Manual RELACIÓN DE CONTENIDO / PACKING LIST Página 1 de 2 DATOSPIR MICRO 511-A08-010 REV. 13 2019-03 MODELOS / MODELS CANT. CÓDIGO DESCRIPCIÓN QTY. CODE DESCRIPTION ________ DATOSPIR MICRO MODELO / MODEL SN: 11A- 04194 CÓDIGO DESBLOQUEO (PUK) / PERSONAL UNBLOCKING KEY (PUK) 02755 PUNTERO / POINTER 09038...
  • Page 20 DATOSPIR MICRO User’s Manual RELACIÓN DE CONTENIDO / PACKING LIST Página 2 de 2 DATOSPIR MICRO 511-A08-010 REV. 13 2019-03 MODELOS / MODELS CANT. CÓDIGO DESCRIPCIÓN QTY. CODE DESCRIPTION 02474 MÓDULO BLUETOOTH BLUETOOTH MODULE 04195 INSTRUCCIONES ADAPTADOR / ADAPTER INSTRUCTIONS 01145 ADAPTADOR BLUETOOTH / BLUETOOTH ADAPTER 02560...
  • Page 21 DATOSPIR MICRO User’s Manual 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.
  • Page 22 DATOSPIR MICRO User’s Manual 1.4 LAYOUT OF CONTROLS, PILOT LIGHTS AND CONNECTORS MODEL A On/off button Alphanumeric LCD display Keypad Turbine transducer USB connection RS·232 series connection Specifications plate Lithium battery (CR1632) Firmware loading switch 10- Main batteries (2xAA 1.5V) MODELO B/C 511-A00-MU2 •...
  • Page 23 DATOSPIR MICRO User’s Manual 1- On/off button 2- Graphic LCD display 3- Turbine transducer 4- USB connection 5- RS·232 series connection 6- Specifications plate 7- Lithium battery (CR1632) 8- Firmware loading switch 9- Main batteries (2xAA 1.5V) 511-A00-MU2 • REV. 2.06...

  • Page 24: Installation And Start-Up

    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.

  • Page 25: Usb Module Installation

    DATOSPIR MICRO User’s Manual In models B and C, in order to save power, Lcd backlight will be switched off if the equipment is not used in 20 seconds. WARNING: When inserting the batteries for the first time or when changing them, the equipment may switch on automatically.

  • Page 26: Bluetooth Module Installation

    DATOSPIR MICRO User’s Manual 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.
  • Page 27 To start the DATOSPIR MICRO spirometer, press the key The equipment will then make a beeping sound and will check itself. The «SIBELMED» logo, the name of the equipment, the programme version and the address of SIBEL, S.A.U. will appear on screen for two seconds.

  • Page 28: Handling The Equipment

    DATOSPIR MICRO User’s Manual NOTE: The first time the equipment is started, the protection is disabled and the PIN is set to 0000. See Section 2.2/3.2 EQUIPMENT CUSTOMISATION to enable it and configure the PIN. HANDLING THE EQUIPMENT The spirometer has been developed to make it user-friendly, so that it is easy and simple to use.

  • Page 29: Hospital Mode

    DATOSPIR MICRO User’s Manual See section 2.12 / 3.13 PATIENT 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 are saved in an internal database and subsequently transferred to the PC database for data analysis and storage.
  • Page 30 DATOSPIR MICRO User’s Manual . Equipment check . Equipment configuration . ATS curves • Function modes . Patient . Hospital • Bluetooth 511-A00-MU2 • REV. 2.06...
  • Page 31 DATOSPIR MICRO User’s Manual . MODEL A OPERATION 511-A00-MU2 • REV. 2.06...

  • Page 32: Function Tree

    DATOSPIR MICRO User’s Manual All of the sections in this Chapter (except for 2.12 PATIENT 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.
  • Page 33 DATOSPIR MICRO User’s Manual 3. Diagnosis 4. Save DB 5. Save PRE 6. Report 7. Delete 8. New patient 2. VC (Slow Vital Capacity Test) 1. Start manoeuvre 2. Results 3. Save DB 4. Save PRE 5. Report 6. Delete 7.
  • Page 34 DATOSPIR MICRO User’s Manual 2. CALIBRATION 1. Calibration 2. DB calibration 1. Register Data 2. Delete Register 3. Report 3. DATABASE 1. Search DB 1. Results 2. (Diagnosis) 3. Report 4. Delete test 2. Search patient 3. Search register 4. Summarised report 5.
  • Page 35 DATOSPIR MICRO User’s Manual 3. Printers 4. Standard 1. Retrieve standard 2. Modify standard 5. Battery 6. Language 7. Set clock 8. Pin 5. MAINTENANCE 1. Warnings 2. LCD contrast 3. Equipment check 1. Printer 2. CPU 3. LCD 4.Keypad 5.
  • Page 36 DATOSPIR MICRO User’s Manual 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...
  • Page 37 DATOSPIR MICRO User’s Manual 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 PATIENT MODE In this option it is possible to configure the DATOSPIR MICRO for use in patient mode.

  • Page 38: Standard Configuration

    DATOSPIR MICRO User’s Manual 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.
  • Page 39 DATOSPIR MICRO User’s Manual 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...

  • Page 40: Equipment Protection

    DATOSPIR MICRO User’s Manual 2.3 EQUIPMENT PROTECTION If equipment protection has been enabled, the following screen will appear when it is started: ENTER PIN Pin: 0000 Enter PIN. If the PIN configured in Equipment protection customisation is entered, access will be given to the DATOSPIR MICRO and the main screen will appear.
  • Page 41 DATOSPIR MICRO User’s Manual 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 «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 and...
  • Page 42 DATOSPIR MICRO User’s Manual Select the digits using the keys or set the value for each digit. Press the key to go to the next and so on in the remaining screens indicated. PATIENT DETAILS Age (years): xx Between 4 and 100 PATIENT DETAILS Height (cm): xxx Between 50 and 230 cm...
  • Page 43 DATOSPIR MICRO User’s Manual 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. key to go to the FVC TEST screen.
  • Page 44 DATOSPIR MICRO User’s Manual FVC TEST 5 Save PRE Saves in the Database as PRE FVC TEST 6 Report Prints the report on any completed manoeuvre FVC TEST 7 Delete Deletes any manoeuvre FVC TEST 8 New Patient Option to change patient or to change some datails of an existing patient ENTERING FORCED VITAL CAPACITY «FVC»...
  • Page 45 DATOSPIR MICRO User’s Manual When undertaking spirometry, take the following steps into account: Check that the turbine is correctly inserted with the mouthpiece, as in the figure. INSERT FIRMLY Instruct the patient as to how to carry out the test, as his cooperation is vital for it to be completed correctly.
  • Page 46 DATOSPIR MICRO User’s Manual FVC TEST Select the screen 1 Start Manoeuv. and press the . 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.
  • Page 47 DATOSPIR MICRO User’s Manual At the end of the manoeuvre, one or more of the Warnings, if enabled in the Customisation Programme, may appear to warn that the manoeuvre is not compliant with ATS/ERS Criteria. An indication is given to inform that the manoeuvre has not been carried out according to one of the following ATS/ERS criteria: ET - Indicates that spiration has not completed satisfactorily, as the variation on volume in the last second of the manoeuvre was...
  • Page 48 DATOSPIR MICRO User’s Manual X.XX YY% FEV1: x.xx 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: % between the Observed value and the value of Reference.

  • Page 49: Displaying Results

    DATOSPIR MICRO User’s Manual If three or more manoeuvres have been completed and the FVC and/or FEV1 parameters are flashing, this indicates that the repeatability criterion for one or both parameters has been met. This criterion indicates that the best two observed values of FVC and the 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.
  • Page 50 DATOSPIR MICRO User’s Manual Press the key and a similar screen to the following will appear: RESULTS M1 M2 [M3] M4 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: •...
  • Page 51 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.
  • Page 52 DATOSPIR MICRO User’s Manual Obstructive ventilatory disturbance FEV1 < 80% Slight FEV1 < 65% Moderate FEV1 < 50% Intense FEV1 < 35% Very Intense If FEV1/FVC% > FEV1/FVC% Reference and FVC < 80% of the FVC Reference Non-obstructive ventilatory disturbance FVC <...
  • Page 53 DATOSPIR MICRO User’s Manual FVC TEST 4 Save DB Press the key and a similar screen to the following will appear, depending on the number of manoeuvres made: SAVE DB M1 M2 [M3] M4 M5 • The manoeuvres are ordered according to ATS/ERS criteria (*), with M1 the best and M5 the worst.
  • Page 54 DATOSPIR MICRO User’s Manual (*) ATS/ERS criteria: The manoeuvre with least warnings is considered the best (ET, EX). With the same number of warnings, the manoeuvre with the highest value sum of FVC+FEV1 is considered the best. Memorising a test to compare it in POST bronchial dilation mode This options allows for a test to be saved in PRE bronchial dilation mode to then compare it with POST bronchial dilation mode.
  • Page 55 DATOSPIR MICRO User’s Manual 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.
  • Page 56 DATOSPIR MICRO User’s Manual The printer will present a report similar to the following: 511-A00-MU2 • REV. 2.06...
  • Page 57 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 «M1»...
  • Page 58 DATOSPIR MICRO User’s Manual FVC TEST 7 Delete Press the key and a similar screen to the following will appear: DELETE [M1] M2 Select the manoeuvre to delete (flashing) and press The following screen will appear: WANT TO DELETE THE MANOEUVRE? Press the key to cancel and not delete the manoeuvre.
  • Page 59 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 •...
  • Page 60 DATOSPIR MICRO User’s Manual If you wish to modify some details of an existing, enter his code. Follow the procedure designed in the ENTERING PATIENT PARAMETERS procedure to enter the details of a new patient or to modify the details 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...
  • Page 61 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 «FVC» PROCEDURE with the following variations: If the test is carried out on the same patient, as described in the OTHER TESTS ON THE SAME PATIENT section, go back using the key to the Test Selection...
  • Page 62 DATOSPIR MICRO User’s Manual 2.6 PROCEDIMIENTO DE LA PRUEBA DE 511-A00-MU2 • REV. 2.06...
  • Page 63 DATOSPIR MICRO User’s Manual 2.6 MAXIMUM VOLUNTARY VENTILATION «MVV» TEST PROCEDURE The procedure to carry out the Maximum Voluntary Ventilation «MVV» test is similar to that described in Section 2.4 FORCED VITAL CAPACITY «FVC» PROCEDURE with the following variations: If the test is carried out on the same patient, as described in the OTHER TESTS ON THE SAME PATIENT section, go back using the key to the Test Selection...
  • Page 64 DATOSPIR MICRO User’s Manual 511-A00-MU2 • REV. 2.06...
  • Page 65 DATOSPIR MICRO User’s Manual 2.7 POST BRONCHIAL DILATOR SPIROMETRY SPIROMETRY PROCEDUR 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.

  • Page 66: Calibration Procedure

    DATOSPIR MICRO User’s Manual DILATION 1 PRE manoeuvres and press The tests memorised in PRE mode will then be displayed. Select the PRE test with which it is to be compared and press The proceed as indicated in Section 2.4 FVC TEST PROCEDURE.
  • Page 67 DATOSPIR MICRO User’s Manual 511-A00-MU2 • REV. 2.06...

  • Page 68: General Observations

    DATOSPIR MICRO User’s Manual 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.
  • Page 69 DATOSPIR MICRO User’s Manual Start the DATOSPIR MICRO using the key and wait for the following screen to appear: MAIN MENU 1 Spirometry With the keys select: MAIN MENU 2 Calibration Press , the following screen will appear: CALIBRATION 1 Calibration Press and enter the volume of the syringe in litres 511-A00-MU2 •...
  • Page 70 DATOSPIR MICRO User’s Manual (between 0 and 6 litres, depending on the syringe) CAL. DATA Volume (l): x If a 0 is entered, the default factors are used (Fct = 1 and NPulses = 188) and the calibration process is completed. NOTE: Where no syringe is available, the value entered in Volume is not relevant and is not taken into account when...
  • Page 71 DATOSPIR MICRO User’s Manual 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.

  • Page 72: Calibration Register

    DATOSPIR MICRO User’s Manual CAL. DATA Pres(mmHg): xxx Press , the following screen will appear: CALIBRATION Start Calibra. Press 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.
  • Page 73 DATOSPIR MICRO User’s Manual 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...

  • Page 74: Internal Database

    DATOSPIR MICRO User’s Manual 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.
  • Page 75 DATOSPIR MICRO User’s Manual Search for a register Print a summarised report 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 keys, select the option: MAIN MENU 3 Database Press the key...

  • Page 76: Patient Search

    DATOSPIR MICRO User’s Manual Select the option: DATABASE 1 Search DB to display the results of the tests saved in the database, consult the diagnosis of each one (if the option is enabled), print a report or delete a test from the database. Press the key and with select...

  • Page 77: Delete Database

    DATOSPIR MICRO User’s Manual to search for a patient in the database. Press the key and enter the patient code. REGISTER SEARCH Select the option: DATABASE 3 Search Reg. to search for a register in the database. Press the key and enter the register number. SUMMARISED REPORT Select the option: DATABASE...

  • Page 78: Maintenance Programme

    DATOSPIR MICRO User’s Manual 2.10 MAINTENANCE PROGRAMME The equipment has a maintenance programme to adjust and/or check the working order of certain options. From the Main screen, press keys to choose: MAIN MENU 5 Maintenance Press the key to access the Maintenance options. Using keys , you can move around the different options to:...
  • Page 79 DATOSPIR MICRO User’s Manual 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.

  • Page 80: Lcd Contrast

    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. 2.06...
  • Page 81 DATOSPIR MICRO User’s Manual to see the values of the following variables: No. Pulses: 0150 Turbine Fact: 200 Alk. B.:OK +4V:OK Li B 26ºC 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.
  • Page 82 DATOSPIR MICRO User’s Manual 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 number of errors in the write/ read process.

  • Page 83: Equipment Configuration

    DATOSPIR MICRO User’s Manual EQUIPMENT CONFIGURATION Select the option: MAINTENANCE 4 Config. Equip. This option allows for different options of the equipment to be configured. Using keys select: CONFIG. EQUIP. 1 Reset to reset all equipment variables. CONFIG. EQUIP. 2 Reindex to reindex the database.
  • Page 84 DATOSPIR MICRO User’s Manual 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...

  • Page 85: Updating Internal Software

    DATOSPIR MICRO User’s Manual 2.11 UPDATING INTERNAL SOFTWARE The DATOSPIR MICRO spirometer has two types of internal software: • Bios (basic hardware control programme) • Flash (programme containing all the equipment options) The update option allows for the version of Bios and/or Flash to be updated without having to take the equipment to the factory and without having to open it.

  • Page 86: Flash Update

    DATOSPIR MICRO User’s Manual WARNING This option should be carried out by an expert or specialist. Turn the equipment and support it on the table with the screen visible. Press the key for 1 second and release. Nothing will appear on the screen. Copy the Bios file (DMBios.tsk) into the \FIRMWARE directory of the application (W20).
  • Page 87 DATOSPIR MICRO User’s Manual 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.
  • Page 88 DATOSPIR MICRO User’s Manual programme in BIOS to update FLASH. The BIOS access key is then requested (Press and then ) to prevent any user from being able to access by mistake. Copy the new file provided by SIBEL containing the update (DMFlash.tsk) to the \FIRMWARE directory of the application (W20).
  • Page 89 DATOSPIR MICRO User’s Manual 2.12 PATIENT OPERATIONS The DATOSPIR MICRO spirometer is very useful to monitor and control asthmatic patients or others to suit the specialist’s criteria. In this option, the spirometer is extremely user-friendly equipment, as the sequence of instructions on the screen will guide patients during spirometric manoeuvres.
  • Page 90 DATOSPIR MICRO User’s Manual Using the keys, select the option: MAIN MENU 4 Customise and then CUSTOMISATION 2 Patient Mode Patient mode customisation includes the customisation of the patient’s details and the test data. Select: PATIENT MODE 1 Patient Details and enter the data requested on the successive screens PATIENT DETAILS Code: xxxxxxxxxx...
  • Page 91 DATOSPIR MICRO User’s Manual PATIENT DETAILS Sex: Female Between male and female PATIENT DETAILS Cig/day: xx Between 0 and 20 cigarettes Select PATIENT 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.
  • Page 92 DATOSPIR MICRO User’s Manual 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 Warning RED Zone...
  • Page 93 DATOSPIR MICRO User’s Manual TEST DAYS Days of the week when MoTuWeThuFrSaSu the tests are taken Patient 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...
  • Page 94 DATOSPIR MICRO User’s Manual programme version and the bios version (programme run during booting), the date and the time. • If start-up is automatic (because it is the time programmed in Alarms): 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.
  • Page 95 DATOSPIR MICRO User’s Manual 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: •...
  • Page 96 DATOSPIR MICRO User’s Manual The following warning will appear on screen after a few seconds: RELEASE THE KEYS You should then release keys 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.
  • Page 97 DATOSPIR MICRO User’s Manual . MODELS B AND C OPERATION 511-A00-MU2 • REV. 2.06...
  • Page 98 DATOSPIR MICRO User’s Manual All of the sections in this Chapter (except for 3.13 PATIENT 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.
  • Page 99 DATOSPIR MICRO User’s Manual SPIROMETRY • 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 Manoeuvre data selected...
  • Page 100 DATOSPIR MICRO User’s Manual CALIBRATION • Calibration using a syringe • Report on the latest calibrations DATABASE • Search by patient code or register number • Summarised display of the tests saved • Printing and displaying a test • Deleting a test •...
  • Page 101 DATOSPIR MICRO User’s Manual Printing VC Volume/Time graph Printing MVV Volume/Time graph Diagnosis selection Comparison mode in POST bronchial dilation Weighted % between PRE and POST % between REF and POST % between PRE and POST Difference between PRE and POST Printout of warnings of Non-Compliant manoeuvres with ATS/ERS criteria •...
  • Page 102 DATOSPIR MICRO User’s Manual DILATION • Carrying out Post bronchial dilation test REPORT • Printing a report BLUETOOTH • Enabling or disabling Bluetooth 511-A00-MU2 • REV. 2.06...
  • Page 103 DATOSPIR MICRO User’s Manual 3.2 EQUIPMENT CUSTOMISATION Every user should customise the DATOSPIR MICRO spirometer according to their requirements due to the variety of options included. The different options included in the Customisation menu are explained in detail in the previous section. To access this option, press CUSTOMISATION in the main menu.
  • Page 104 DATOSPIR MICRO User’s Manual SPIROMETRY CUSTOMISATION This option customises any suboptions specific to the spirometric tests 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.
  • Page 105 DATOSPIR MICRO User’s Manual Mode of comparison between PRE bronchial and POST bronchial W Average weighted % between PRE and POST % between REF and POST % 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 PATIENT MODE...
  • Page 106 DATOSPIR MICRO User’s Manual Restores the standard configuration Saves the standard configuration Follow the instructions below to save the Standard configuration: Customise each of the following options: Patient mode customisation Database customisation Common customisation Spirometry customisation Protection customisation as described in this section. Go back to the Standard Configuration option and press the Your Standard Configuration has now been memorised.
  • Page 107 DATOSPIR MICRO User’s Manual COMMON CUSTOMISATION This option customises certain suboptions that are common to any test made using the DATOSPIR MICRO. Sets the internal equipment clock (time and date) Mode (alphanumeric or numeric) Battery type (alkaline or NiMh) This selection only affects the calculation made inside the equipment to indicate the battery level Operating language...
  • Page 108 DATOSPIR MICRO User’s Manual 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 To enable the protection, tick the Pin Enabled checkbox and enter the PIN in the New Pin boxes.
  • Page 109 DATOSPIR MICRO User’s Manual 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. 511-A00-MU2 • REV. 2.06...
  • Page 110 DATOSPIR MICRO User’s Manual 3.3 EQUIPMENT PROTECTION If equipment protection has been enabled, the following screen will appear when it is started: Enter the PIN and press If the PIN configured in Equipment protection customisation is entered, access will be given to the DATOSPIR MICRO and the main screen will appear.
  • Page 111 DATOSPIR MICRO User’s Manual 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.
  • Page 112 DATOSPIR MICRO User’s Manual 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,...
  • Page 113 DATOSPIR MICRO User’s Manual 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. (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.
  • Page 114 DATOSPIR MICRO User’s Manual ENTERING FORCED VITAL CAPACITY «FVC» TESTS Go back to the previous screen Start the manoeuvre Save the manoeuvre on 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 Print the manoeuvre report...
  • Page 115 DATOSPIR MICRO User’s Manual the data on the selected manoeuvre. • Pressing on a manoeuvre selects it. This allows you to see its graph, consult its parameters or print a report. • Pressing on the graph area makes the buttons disappear and makes it larger or smaller.
  • Page 116 DATOSPIR MICRO User’s Manual When undertaking spirometry, take the following steps into account: Check that the turbine is correctly inserted with the mouthpiece, as in the figure INSERT FIRMLY Instruct the patient as to how to the test is being carried out, as his cooperation is vital for it to be completed correctly.
  • Page 117 DATOSPIR MICRO User’s Manual 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 the key The equipment is held so that the doctor can see the screen while the patient is carrying out the tests.
  • Page 118 DATOSPIR MICRO User’s Manual At the end of the manoeuvre, one or more of the Warnings, if enabled in the Customisation Programme, may appear to warn 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...
  • Page 119 DATOSPIR MICRO User’s Manual • The new graph is superimposed to compare it with the best (M1/ dotted line) of those saved. • 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 (*).
  • Page 120 DATOSPIR MICRO User’s Manual 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 Save the selected manoeuvre in the database Display the remaining parameters, if selected •...
  • Page 121 DATOSPIR MICRO User’s Manual - 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...
  • Page 122 DATOSPIR MICRO User’s Manual • Snider, Kory & Lyons Diagnosis This is based on the following criteria: If FVC > 80% of the FVC Reference and FEV1 > 80% of the FEV1 Reference Values in the range of reference. Normal Diagnosis If FEV1/FVC% <...
  • Page 123 DATOSPIR MICRO User’s Manual If FEV1/FVC% < FEV1/FVC% Reference and FEV1 > 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...
  • Page 124 DATOSPIR MICRO User’s Manual 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 «H», depending on its capacity. The manoeuvre selected by default is the best (M1).
  • Page 125 DATOSPIR MICRO User’s Manual 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 database has been selected, on the test screen press the key The following screen will appear:...
  • Page 126 DATOSPIR MICRO User’s Manual PRINTING THE FVC The DATOSPIR MICRO spirometer can print any manoeuvre made using an external printer. The manoeuvre selected by default is the best (M1). If you want to produce a report on another, it must first be selected. Check that the printer is ready and connected.
  • Page 127 DATOSPIR MICRO User’s Manual 511-A00-MU2 • REV. 2.06...
  • Page 128 DATOSPIR MICRO User’s Manual 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).
  • Page 129 DATOSPIR MICRO User’s Manual 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 •...
  • Page 130 DATOSPIR MICRO User’s Manual 3.5 SLOW VITAL CAPACITY «VC» TEST PROCEDURE The procedure to carry out the slow Vital Capacity «VC» test is similar to that described in section 3.4 FORCED VITAL CAPACITY «FVC» PROCEDURE with the following variations: Access the «VC» test by pressing the key from the main screen and perform a manoeuvre.
  • Page 131 DATOSPIR MICRO User’s Manual 511-A00-MU2 • REV. 2.06...
  • Page 132 DATOSPIR MICRO User’s Manual 3.6 «MVV» 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: Access the «MVV» test by pressing the key from the main screen and perform a manoeuvre.
  • Page 133 DATOSPIR MICRO User’s Manual 511-A00-MU2 • REV. 2.06...
  • Page 134 DATOSPIR MICRO User’s Manual 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.
  • Page 135 DATOSPIR MICRO User’s Manual Using keys , 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: Then continue as described in section 3.4 FVC TEST PROCEDURE.
  • Page 136 DATOSPIR MICRO User’s Manual • In this case, the curve in POST bronchial mode is compared with the curve saved in PRE bronchial mode. • The data screen shows the observed values in PRE and POST mode and the method of comparison between them, depending on the option selected in customisation.
  • Page 137 DATOSPIR MICRO User’s Manual 511-A00-MU2 • REV. 2.06...
  • Page 138 DATOSPIR MICRO User’s Manual 3.8 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.
  • Page 139 DATOSPIR MICRO User’s Manual From the Main screen, press the key The following screen will appear: If there are previous calibrations, the details of the last one will appear in the title. Enter the necessary data: Volume (volume of the syringe): between 0 and 6 litres, depending on the syringe.
  • Page 140 DATOSPIR MICRO User’s Manual the following screen will appear: Volume: Nº Pulses: Check that Nº of pulses is the same that on the turbina Press and the factors will be calculated and the calibration process completed. In case of pressing the number of pulses will not change and will return to the previous screen.
  • Page 141 DATOSPIR MICRO User’s Manual Press . If a Volume other than 0 has been entered and the No. of Pulses has not bee modified, the following screen will appear: 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).
  • Page 142 DATOSPIR MICRO User’s Manual Once calibrated, exit the Calibration Programme and access the Spirometry programme to begin the tests. Note: If, upon entering the calibration parameters in point , “Calibration Volume (l): 0” is allocated, the system takes the calibration factors “EXP F. and INS F.:1.00”, corresponding to original factory calibration.
  • Page 143 DATOSPIR MICRO User’s Manual Deletes a 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 •...

  • Page 144: Internal Database

    DATOSPIR MICRO User’s Manual 3.9 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.
  • Page 145 DATOSPIR MICRO User’s Manual Print a summarised report Delete the database To do so, start the DATOSPIR MICRO using the key and wait for the following screen to appear: Press to access the screen with the options to be chosen with the database. Go back to the main screen 511-A00-MU2 •...
  • Page 146 DATOSPIR MICRO User’s Manual 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 Go back to the previous screen and Fast back/forwards through the registers 511-A00-MU2 •...
  • Page 147 DATOSPIR MICRO User’s Manual The movement value is configured in the Customisation menu. Deletes the test selected Displays the test selected Moves around the different tests Select a test and press . The following screen is accessed: Go back to the previous screen Display test data Display the test diagnosis Print the test...
  • Page 148 DATOSPIR MICRO User’s Manual PATIENT SEARCH Select the option to search for a patient in the database. The following screen will appear: 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».
  • Page 149 DATOSPIR MICRO User’s Manual 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.
  • Page 150 DATOSPIR MICRO User’s Manual DELETE DATABASE Select the option to delete the database. The following message will appear: Press to accept and delete the database or press go back to the previous screen without deleting it. 511-A00-MU2 • REV. 2.06...
  • Page 151 DATOSPIR MICRO User’s Manual 3.10 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 Enables the calibration and/or maintenance warnings Adjusts the screen contrast TouchPannel calibration Auto-checks the equipment Checks with pre-saved standard curves...
  • Page 152 DATOSPIR MICRO User’s Manual maintenance work, the tests performed and the tests performed since the last maintenance work. Press 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.

  • Page 153: Equipment Check

    DATOSPIR MICRO User’s Manual Go back to the previous screen Black background/white content White background/black content Validate choice Increase/decrease contrast EQUIPMENT CHECK Select the option to check different parts of the equipment. 511-A00-MU2 • REV. 2.06...
  • Page 154 Go back to the previous screen Distributor details Check the external printer selected. The SIBELMED logo, the heading lines and 10 lines of characters will be printed. Check that the automatic on and off work properly. Upon selecting this option, the equipment switches off and on automatically after 5 seconds.

  • Page 155: Standard Curves

    DATOSPIR MICRO User’s Manual Performs a test on the LCD. Follow the instructions given on the screen. Touch Screen STANDARD CURVES Select the option to check the working order of the equipment through certain pre-saved curves. Select the curve type and follow the instructions on the screen, which are similar to the FVC, VC and MVV procedures.
  • Page 156 DATOSPIR MICRO User’s Manual EQUIPMENT CONFIGURATION Select the option to configure different options of the equipment. Go back to the previous screen Reset all equipment variables. Reindex the database. Change from positive VC to negative VC and vice versa • An updating key is also displayed, which is necessary for updating the equipment and obtaining a new, improved version of it.
  • Page 157 DATOSPIR MICRO User’s Manual 3.12 UPDATING INTERNAL SOFTWARE The DATOSPIR MICRO spirometer has two types of internal software: • Bios (basic hardware control programme) • Flash (programme containing all the equipment options) The update option allows for the version of Bios and/or Flash to be updated without having to take the equipment to the factory and without having to open it.
  • Page 158 DATOSPIR MICRO User’s Manual WARNING This option should be carried out by an expert or specialist. Turn the equipment and support it on the table with the screen visible. Press the On-Off key for 1 second and release it. Nothing will appear on the screen.
  • Page 159 DATOSPIR MICRO User’s Manual 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.
  • Page 160 DATOSPIR MICRO User’s Manual 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.
  • Page 161 DATOSPIR MICRO User’s Manual 3.12 PATIENT MODE OPERATION The DATOSPIR MICRO spirometer is very useful for monitoring and controlling asthmatic patients or others to suit the specialist’s criteria. With this option, the spirometer is extremely user-friendly equipment, as the sequence of instructions on-screen will guide patients during spirometric manoeuvres.
  • Page 162 DATOSPIR MICRO User’s Manual Patient mode customisation includes the customisation of the patient’s details and the test data. Press and enter the patient’s details. 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...
  • Page 163 DATOSPIR MICRO User’s Manual 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.
  • Page 164 DATOSPIR MICRO User’s Manual The alarms are a reminder for the patient, as the test can be taken at any time, despite it being different to the time programmed, and the time it is taken is recorded. Programme the alarms for each test. Select the days of the week on which the tests are to be performed.
  • Page 165 DATOSPIR MICRO User’s Manual Patient mode is now configured, so that you simply have to press on the main screen to enable it and to switch off the equipment. ACQUISITION OF SPIROMETRIC TESTS Once the equipment has been configured by the specialist the test acquisition process can begin.
  • Page 166 DATOSPIR MICRO User’s Manual 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 The following screen will appear: The patient can start the manoeuvre after the arrow has appeared (they have 30 seconds).
  • Page 167 DATOSPIR MICRO User’s Manual The patient must perform three expiratory manoeuvres and the following screen will appear: 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: •...
  • Page 168 DATOSPIR MICRO User’s Manual • HIGH To do so, press to go to the next screen or 511-A00-MU2 • REV. 2.06...
  • Page 169 DATOSPIR MICRO User’s Manual Upon pressing the following screen appear, indicating that the test has been saved on the database: IMPORTANT NOTE Proceed as follows to go from PATIENT MODE to HOSPITAL MODE: Stop equipment with the key 511-A00-MU2 • REV. 2.06...
  • Page 170 DATOSPIR MICRO User’s Manual Keep the lower right of the screen pressed down and restart by pressing The following warning will appear on screen after a 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...

  • Page 171: Communications System

    DATOSPIR MICRO User’s Manual . COMMUNICATIONS SYSTEM 511-A00-MU2 • REV. 2.06...
  • Page 172 DATOSPIR MICRO User’s Manual 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: •...
  • Page 173 DATOSPIR MICRO User’s Manual 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: Start the DATOSPIR MICRO and select Maintenance from the Main screen.
  • Page 174 DATOSPIR MICRO User’s Manual Load the files to your normal e-mail programme and send to the SIBEL, S.A.U. 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.

  • Page 175: Exporting Tests To Other Systems

    DATOSPIR MICRO User’s Manual 4.3 EXPORTING TESTS TO OTHER SYSTEMS The DATOSPIR MICRO spirometer can export the tests saved previous to the Internal Database to other management systems in each hospital. The equipment shows the information in comma-delimited mode, making it compatible with many different systems. The information is available in the following files: PRUEBAS.
  • Page 176 DATOSPIR MICRO User’s Manual 4.4 SPIROMETRY SOFTWARE W-20 FOR See the W-20 Spirometry Software User’s Manual for all related information. 511-A00-MU2 • REV. 2.06...
  • Page 177 DATOSPIR MICRO User’s Manual . TECHNICAL SPECIFICATIONS 511-A00-MU2 • REV. 2.06...
  • Page 178 DATOSPIR MICRO User’s Manual 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 TEST, FUNCTIONS AND PARAMETERS FORCED VITAL CAPACITY FVC Parameters: • FVC Forced Vital Capacity •...
  • Page 179 DATOSPIR MICRO User’s Manual • FIF50% (l/s) Maximum Inspiratory flow with 50% of FVC inspired • FIVC Forced Vital Inspiratory Capacity • FIV1 Forced Inspirometry Volume in 1 second • FIV1/FIVC Ratio • FEV1/FIV1 Ratio • PIF (l/s) Inspiratory Flow Apex •...
  • Page 180 DATOSPIR MICRO User’s Manual 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: •...
  • Page 181 DATOSPIR MICRO User’s Manual MAXIMUM VOLUNTARY VENTILATION Parameters: • MVV (l/min) Maximum Voluntary Ventilation • Br./min (Br/min) Breathing frequency of MVV Percentage deviation in relation to values of reference Standardised values of reference that can be selected from several standards Patient’s ID details Atmospheric data on temperature, pressure and relative humidity...

  • Page 182: Clock-Calendar

    DATOSPIR MICRO User’s Manual CUSTOMISATION PROGRAMME User-selected STANDARD configuration Customisation of the language, printer and report heading, etc. Spirometry customisation Parameters of reference Observed parameters Graph selection Diagnosis selection Report customisation ... INTERNAL DATABASE Saving of spirometric tests. Two types of database according to their storage capacity CLOCK-CALENDAR Hour-Minute-Second Day-Month-Year...

  • Page 183: Measuring System

    DATOSPIR MICRO User’s Manual 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. RANGES AND MEASUREMENTS Turbine •...
  • Page 184 DATOSPIR MICRO User’s Manual 5.3 MICRO CONTROLLER System micro controller: • Hitachi H8S2144 Volume accumulation time: • Five FVC curves with a maximum of 25 seconds each • Five VC curves with a maximum of 45 seconds each • Five MVV curves with a maximum of 15 seconds each Start FVC expiration: •...

  • Page 185: Temperature Sensor

    DATOSPIR MICRO User’s Manual • All instructions, data, etc. transmitted by the operator to the microprocessor involve a keypad with silicon keys (Model A) or a touch screen (Models B and C). Comunication channel: • RS 232C • USB 2.0 •...
  • Page 186 DATOSPIR MICRO User’s Manual Temperature: • Storage, between -5 and 70 °C • Working, between 5 and 40 °C Power supply: • 1.5 V battery (alkaline recommended) or 1.2 NiMh battery (recommended > 2200mAh). Power: • Below 400 mW Size: •...
  • Page 187 DATOSPIR MICRO User’s Manual ELECTRICAL SAFETY • EN 60601-1:2006-AC:2010 +A11:2011+A1:2013 Seg. medical equipment. Class IP (Internally powered). Continuous use. • EN 60601-1-2:2015 EMC in medical equipment. APPENDIX 1. ELECTROMAGNETIC COMPATIBILITY SPIROMETRY Standards: • EN ISO 26782:2009+AC:2009 Equipment of Anaesthetic and respiratory resuscitation.
  • Page 188 DATOSPIR MICRO User’s Manual USABILITY AND APTITUDE FOR USE • EN 60601-1-6:2010+A1:2015 General requirements for safety. Part 1-6. Collateral standard: Usability • EN 62366:2008+A1:2015 Application of engineering skills to use medical devices BIOCOMPATIBILITY • ISO 10993.1:2009+AC:2010 Biological evaluation of medical devices.
  • Page 189 DATOSPIR MICRO User’s Manual • EN ISO 9001:2015 quality management. Requirements • EN ISO 14971:2012 Risk management in medical equipment WASTE • RD 110/2015 Electrical and electronic equipment and waste management. Transposition of WEEE 2012/19/UE Directive To be satisfied by the user DATA PROTECTION •...
  • Page 190 DATOSPIR MICRO User’s Manual 5.6.1 SIMBOLOGY SERIAL NUMBER MANUFACTURER (The date of manufacture, name and address of manu- facturer) TEMPERATURE LIMITATION HUMIDITY LIMITATION PREASURE LIMITATION DIRECTIONS FOR US EXPIRY DATE CAUTION 511-A00-MU2 • REV. 2.06...
  • Page 191 DATOSPIR MICRO User’s Manual DISPOSAL OF WASTE ELECTRICAL / ELECTRONIC AGREEMENT TO THE WEE DIRECTIVE DO NOT REUSE START-UP (STANDBY) BF APPLIED PART B APPLIED PART 511-A00-MU2 • REV. 2.06...
  • Page 192 DATOSPIR MICRO User’s Manual 511-A00-MU2 • REV. 2.06...

  • Page 193: Operating Principles

    DATOSPIR MICRO User’s Manual . OPERATING PRINCIPLES 511-A00-MU2 • REV. 2.06...
  • Page 194 DATOSPIR MICRO User’s Manual 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.

  • Page 195: Physical Description

    DATOSPIR MICRO User’s Manual 6.3 MICROPROCESSOR PHYSICAL DESCRIPTION The microprocessor system is made up of a series of electronic devices that save, manage, receive and send data. In general terms, it is divided into: - Basic hardware control programme (BIOS) residing in the internal Flash of the Micro controller (128 KBytes).
  • Page 196 DATOSPIR MICRO User’s Manual 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.
  • Page 197 DATOSPIR MICRO User’s Manual Turbine Any ageing of or accumulated dirt in the turbine transducer may lead to imprecise measurements. To ensure the turbine measures correctly, the system includes a simple checking procedure based on measuring the known volume of a calibration syringe. 511-A00-MU2 •...
  • Page 198 DATOSPIR MICRO User’s Manual 511-A00-MU2 • REV. 2.06...
  • Page 199 DATOSPIR MICRO User’s Manual . SPIROMETRY TECHNIQUE 511-A00-MU2 • REV. 2.06...
  • Page 200 DATOSPIR MICRO User’s Manual 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.
  • Page 201 DATOSPIR MICRO User’s Manual shown to be similar or to have equivalent results. The volume extrapolated using this method must be below 5% of the vital capacity or 150 ml, without exceeding either of the two criteria.” “To ensure good spirometry, the technician will pay particular attention to ensure that the patient has made the utmost effort, that the start has been good and that no coughing or Valsava’s manoeuvre due to glottis closure has occurred.
  • Page 202 DATOSPIR MICRO User’s Manual although at least one of the elements of the biological signal, the volume or the flow, must be reproduced together or separately. Along these lines, the syringes holding several litres provide a suitable signal and the flow generators can be used to assess the precision and errors in flow measurement.
  • Page 203 DATOSPIR MICRO User’s Manual 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**...
  • Page 204 DATOSPIR MICRO User’s Manual “Multi-centre study in Barcelona Variable Equation (Age 6-20) 0.02800T+0.03451P+0.05728E-3.21 0.947 0.443 0.03049T+0.02220P+0.03550E-3.04 0.935 0.313 FEV1 0.02483T+0.02266P+0.07148E-2.91 0.945 0.378 0.02866T+0.01713P+0.02955E-2.87 0.940 0.263 *FEV1/FVC% 0.593E - 0.113P + 81.60 0.026T + 82.60 FEF 25-75% 0.038T + 0.140E - 4.33 0.832 0.796 0.046T + 0.051E - 4.30 0.789 0.651...
  • Page 205 DATOSPIR MICRO User’s Manual M: male; F: female R: multiple correlation coefficient SEE: typical estimate error T: height (cm), P: weight (Kg), E: age (years).» The parameters with an asterisk * are not listed in the SEPAR standard. 7.4 VALUES OF REFERENCE FOR FORCED SPIROMETRY «ECCS.93»...
  • Page 206 DATOSPIR MICRO User’s Manual IMPORTANT NOTE: The DATOSPIR MICRO spirometer allows for an ETHNIC FACTOR to be entered, which modifies the values of reference for certain groups of the population. This factor ranges from 80% to 120% of the values of reference, where 100% is the value according to each table.
  • Page 207 DATOSPIR MICRO User’s Manual . UPKEEP, PREVENTATIVE AND CORRECTIVE MAINTENANCE 511-A00-MU2 • REV. 2.06...
  • Page 208 DATOSPIR MICRO User’s Manual 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.
  • Page 209 DATOSPIR MICRO User’s Manual Top level disinfection: If you suspect microbial contamination, use one of the more complex antiseptic solutions or sterilisation procedures. For example, replace Step by submerging it in a glutaraldehyde solution (or similar) for 10 minutes (follow the manufacturer’s instructions).

  • Page 210: Preventative Maintenance

    DATOSPIR MICRO User’s Manual 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: Every time it is started, the equipment will check certain parts.

  • Page 211: Corrective Maintenance

    DATOSPIR MICRO User’s Manual On all accounts, SIBEL, S.A.U. , 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.
  • Page 212 DATOSPIR MICRO User’s Manual 511-A00-MU2 • REV. 2.06...
  • Page 213 DATOSPIR MICRO User’s Manual APPENDIX 1 ELECTROMAGNETIC COMPATIBILITY 511-A00-MU2 • REV. 2.06...
  • Page 214 DATOSPIR MICRO User’s Manual Guidance and manufacturer’s declaration – electromagnetic emis- sions DATOSPIR MICRO is intended for use in the electromagnetic environment spe- cified below. The customer or the user should assure that it is used in such an environment.. Electromagnetic Emissions test Compliance...
  • Page 215 DATOSPIR MICRO User’s Manual Guidance and manufacturer’s declaration – electromagnetic emissions DATOSPIR MICRO is intended for use in the electromagnetic environment specified below. DATOSPIR MICRO The costumer or the user of should assure that it is used in such an environment.
  • Page 216 DATOSPIR MICRO User’s Manual Guidance and manufacturer’s declaration – electromagnetic immunity DATOSPIR MICRO is intended for use in the electromagnetic environment specified DATOSPIR MICRO below. The costumer or the user of should assure that it is used in such an environment. Below mentioned tests are applicable to enclosure.
  • Page 217 DATOSPIR MICRO User’s Manual Proximity fields EN-IEC 61000-4-3 Frecuency Band Modulation Power Distance (MHz) (MHz) (V/m) 380-390 Pulso 18Hz 430-470 D:+/-5kHz 1kHz sinus 704-787 Pulso 217Hz 800-960 Pulso 18Hz 1720 1700-1990 Pulso 217Hz 1845 1970 2450 2400-2570 Pulso 217Hz 5240 5100-5800 Pulso 217Hz 5500...
  • Page 218 DATOSPIR MICRO User’s Manual 511-A00-MU2 • REV. 2.06...
  • Page 219 DATOSPIR MICRO User’s Manual APPENDIX 2 C O M P L I A N C E W I T H THE DATA PROTECTION REGULATIONS 511-A00-MU2 • REV. 2.06...
  • Page 220 DATOSPIR MICRO User’s Manual COMPLIANCE WITH THE DATA PROTECTION REGULATIONS This section is aimed at facilitating the user to comply with the regulation in force related to the treatment of personal data that are regulated and covered by REGULATION (EU) 2016/679 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data.
  • Page 221 DATOSPIR MICRO User’s Manual 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.

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