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Sibelmed DATOSPIR MICRO A User Manual Download Page 188

Chapter 5: Technical Specifications

DATOSPIR MICRO User’s Manual

188

511-A00-MU2  •  REV. 2.06

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. Part 1.

SOFTWARE

• EN 62304:2006+AC:2008+A1:2015 Software for Medical Devices

DOCUMENTATION AND INFORMATION

•  EN  1041:2008    Information  supplied  by  the  manufacturer  of 

medical devices

• EN ISO 15223-1:2016 Symbols to be used with medical device 

labels, labelling andi nformation to be suplplied.

BLUETOOTH MODULE

•  Compliance with Standard 2.1

•  Class II

•  CE and FCC Certificate.

2.   Related to the manufacturer

QUALITY

•  EN ISO 13485:2016+AC:2018 Quality management systems. 

Requirements for regulatory purposes.

Summary of Contents for DATOSPIR MICRO A

Page 1: ...DATOSPIR MICRO 511 A00 MU2 REV 2 06 2019 03 USER MANUAL SPIROMETER...

Page 2: ...s 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 sa...

Page 3: ...41 2 5 SLOW VITAL CAPACITY VC TEST PROCEDURE 61 2 6 PROCEDIMIENTO DE LA PRUEBA DE 2 6 MAXIMUM VOLUNTARY VENTILATION MVV TEST PROCEDURE 62 2 7 POST BRONCHIAL DILATOR SPIROMETRY SPIROMETRY PROCEDUR 65...

Page 4: ...OFTWARE W 20 FOR PC 176 5 TECHNICAL 177 5 1 TYPES OF TEST FUNCTIONS AND PARAMETERS 178 5 2 MEASURING SYSTEM 183 5 3 MICRO CONTROLLER 184 5 4 PRESENTATION OF DATA 185 5 5 TEMPERATURE SENSOR 185 5 6 GEN...

Page 5: ...Index DATOSPIR MICRO User s Manual 5 511 A00 MU2 REV 2 06 8 2 PREVENTATIVE MAINTENANCE 210 8 3 CORRECTIVE MAINTENANCE 211 APPENDIX 1 213 ELECTROMAGNETIC 213 COMPATIBILITY 213 APPENDIX 2 219...

Page 6: ...Index DATOSPIR MICRO User s Manual 6 511 A00 MU2 REV 2 06...

Page 7: ...nary 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 Ins...

Page 8: ...DATOSPIR MICRO User s Manual 8 Declaration of Conformity 511 A00 MU2 REV 2 06...

Page 9: ...her power sources not indicated in this manual The spirometer is not intended to be used in transport vehicles It is advisable to use the device in an acoustic environment enough silent to allow the p...

Page 10: ...xpiratory maneuver 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...

Page 11: ...t 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 m...

Page 12: ...e 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...

Page 13: ...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 EUROP...

Page 14: ...Safety DATOSPIR MICRO User s Manual 14 511 A00 MU2 REV 2 06...

Page 15: ...Chapter 1 Instructions for Use and Installation DATOSPIR MICRO User s Manual 15 511 A00 MU2 REV 2 06 1 INSTRUCTIONS FOR USE AND INSTALLATION...

Page 16: ...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 I...

Page 17: ...anufactured 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 initia...

Page 18: ...C The enclosed tables show the basic standard features of each model and all other optional parts and functions A model can be upgraded at any time by adding the corresponding parts To do so please c...

Page 19: ...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 PINE...

Page 20: ...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 RVAN...

Page 21: ...y These checks must be carried out by the manufacturer or by skilled technical personnel authorised by SIBEL S A U according to the manufacturer s SIBEL S A Verification and Adjustment Procedures All...

Page 22: ...LAYOUT OF CONTROLS PILOT LIGHTS AND CONNECTORS MODEL A MODELO B C 1 On off button 2 Alphanumeric LCD display 3 Keypad 4 Turbine transducer 5 USB connection 6 RS 232 series connection 7 Specifications...

Page 23: ...O User s Manual 23 511 A00 MU2 REV 2 06 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 Firmwar...

Page 24: ...e 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 wi...

Page 25: ...mmends 17 to 40 C Relative humidity below 95 without condensation 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...

Page 26: ...ssion 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 opti...

Page 27: ...ll 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 If equipment protection is enabled the PIN entry...

Page 28: ...show you that it is truly easy and intuitive for any medical staff All functions are accessible from the 4 silicon keys located underneath the screen Model A or using the icons on the screen that can...

Page 29: ...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 Atmospher...

Page 30: ...Chapter 1 Instructions for Use and Installation DATOSPIR MICRO User s Manual 30 511 A00 MU2 REV 2 06 Equipment check Equipment configuration ATS curves Function modes Patient Hospital Bluetooth...

Page 31: ...Chapter 2 Model A Operating DATOSPIR MICRO User s Manual 31 511 A00 MU2 REV 2 06 2 MODEL A OPERATION...

Page 32: ...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 keys enable you to move around th...

Page 33: ...st 1 Start manoeuvre 2 Results 3 Save DB 4 Save PRE 5 Report 6 Delete 7 New patient 3 MVV Maximum Voluntary Ventilation Test 1 Start manoeuvre 2 Results 3 Save DB 4 Save PRE 5 Report 6 Delete 7 New pa...

Page 34: ...ister 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 Delete DB 4 CUSTOMISATION 1 Spirometry 1 References 1 Adults...

Page 35: ...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 ADCs 6 Inputs 4 Equipment config 1 Reset 2 Reindex 3...

Page 36: ...selected SEPAR ERS KNUDSON CRAPO ZAPLETAL MORRIS AUSTRIA GUTIERREZ CHILI CASTRO BRAZIL POLGAR WENG P PADILLA MEXICO HANKINSON A J CRUZ M XICO GOLSHAN IRAN for adults and children and the ethnic factor...

Page 37: ...R MICRO for use in patient mode See Section 2 12 PATIENT 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 o...

Page 38: ...to that most often used 1 Retrieve Standard The configuration saved can be loaded as standard 2 Modify Standard The configuration to date can be saved for use as standard BATTERY CUSTOMISATION The DAT...

Page 39: ...nt 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 P...

Page 40: ...ous 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 purcha...

Page 41: ...oluntary 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 wait for th...

Page 42: ...ETAILS Height cm xxx Between 50 and 230 cm PATIENT DETAILS Weight Kg xx Between 15 and 200 Kg PATIENT DETAILS Sex Man Between male and female PATIENT DETAILS I Smoker xx Between 0 and 200 packs a day...

Page 43: ...USED and can only be modified through the Customisation Programme Press the key to go to the FVC TEST screen Use the or keys to select one of the following options FVC TEST 1 Start Manoeuvre Allows fo...

Page 44: ...e 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 TESTS The technician to ca...

Page 45: ...or ask for a spirometry course from SIBEL S A U Patients can carry out the spirometry manoeuvres in two different ways The first consists of starting to move the turbine with FORCED EXPIRATION followe...

Page 46: ...ng 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 equ...

Page 47: ...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...

Page 48: ...ue of the References according to the percentage selected 100 is equivalent to the unmodified standard value of the References Using the selection keys or it is possible to view the observed value and...

Page 49: ...itre 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 ch...

Page 50: ...red according to ATS ERS criteria explained in the previous section with M1 the best and M5 the worst The manoeuvre between brackets M3 indicates the position taken by the last manoeuvre entered The f...

Page 51: ...ce The diagnosis and the results of the test must always be validated by the specialist Miller Diagnosis This presents the following information NORMAL RESTRICTIVE OBSTRUCTIVE or COMBINED according to...

Page 52: ...1 FVC FEV1 FVC Reference and FEV1 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...

Page 53: ...o ATS ERS criteria with M1 the best and M5 the worst The manoeuvre between brackets M3 indicates the position taken by the last manoeuvre entered The flasing text indicates the manoeuvre selected the...

Page 54: ...ompare 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...

Page 55: ...cess 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...

Page 56: ...Chapter 2 Model A Operating DATOSPIR MICRO User s Manual 56 511 A00 MU2 REV 2 06 The printer will present a report similar to the following U...

Page 57: ...he 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 T...

Page 58: ...1 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 If you press the key to delete...

Page 59: ...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...

Page 60: ...tient 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 in the datab...

Page 61: ...st Selection window and select using keys or 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 o...

Page 62: ...Chapter 2 Model A Operating DATOSPIR MICRO User s Manual 62 511 A00 MU2 REV 2 06 2 6 PROCEDIMIENTO DE LA PRUEBA DE U...

Page 63: ...TS ON THE SAME PATIENT section go back using the key to the Test Selection window and select using keys or the MVV test SPIROMETRY 3 MVV If the patient is new begin as described in the ENTERING PATIEN...

Page 64: ...Chapter 2 Model A Operating DATOSPIR MICRO User s Manual 64 511 A00 MU2 REV 2 06 U...

Page 65: ...sults of applying a bronchial dilating drug in the same report The procedure to carry out Post bronchial dilating Spirometry is as follows 1 Complete a FVC VC or MVV test on the patient before applyin...

Page 66: ...tion is in point 5 as the is weighted in relation to the observed values in Pre bronchial and Post bronchial mode If the printed report is requested the data is presented as shown below Three columns...

Page 67: ...Chapter 2 Model A Operating DATOSPIR MICRO User s Manual 67 511 A00 MU2 REV 2 06 U...

Page 68: ...e 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 incl...

Page 69: ...2 Start the DATOSPIR MICRO using the key and wait for the following screen to appear MAIN MENU 1 Spirometry 3 With the keys or select MAIN MENU 2 Calibration 4 Press the following screen will appear...

Page 70: ...taken into account when automatically calibrating the equipment 6 Press The following screen will appear CAL DATA No Pulses xxx If the number of pulses associated to its turbine is as appears on scree...

Page 71: ...um 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 The atmospheric tempe...

Page 72: ...orm 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...

Page 73: ...emely useful for centres requiring a quality control of the processes they use To access this register select the option CALIBRATION 2 Calibration DB Press and using keys and access the option require...

Page 74: ...ned off or the batteries are removed There are two bases with the same functions but different capacities Database L Database H The tests that can be saved using a six second FVC as reference are Data...

Page 75: ...y and wait for the following screen to appear MAIN MENU 1 Spirometry Using the or keys select the option MAIN MENU 3 Database Press the key and with or select the required function DATABASE SEARCH The...

Page 76: ...e 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 or select the option required Pat Code...

Page 77: ...R 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 4 Summ Report to prin...

Page 78: ...From the Main screen press keys or to choose MAIN MENU 5 Maintenance Press the key to access the Maintenance options Using keys and you can move around the different options to 1 Configure the calibra...

Page 79: ...splaying a sign every time it is started If 0 days is entered a warning is never given Press and the next screen will appear to enter the calibration period Calibration Period x Press and the next scr...

Page 80: ...s 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 and select EQUIPMENT...

Page 81: ...e Fact 200 Alk B OK 4V OK Li B 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 ch...

Page 82: ...nal RAM The top line indicates the current direction and the bottom line the number of errors in the write read process 0xFFEF00 Err CPU Ram 0 4 Tests the external RAM the same process as for the inte...

Page 83: ...ows for different options of the equipment to be configured Using keys and select CONFIG EQUIP 1 Reset to reset all equipment variables CONFIG EQUIP 2 Reindex to reindex the database CONFIG EQUIP 3 Ca...

Page 84: ...andard Curves This option checks the correct working order of the equipment using pre saved curves Using keys and select STANDARD CURVES 1 FVC STANDARD CURVES 2 VC STANDARD CURVES 3 MVV Select the opt...

Page 85: ...e 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 BI...

Page 86: ...ks 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 tu...

Page 87: ...IN 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 Spi...

Page 88: ...e 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...

Page 89: ...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 Sp...

Page 90: ...ode 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 Cod...

Page 91: ...V1 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...

Page 92: ...etween 80 and 50 Precaution RED Zone Between 50 and 0 Warning SEMAPHORE LEVELS Min xxx Max xxx Select the level where necessary and press The alarms are a reminder for the patient as the test can be t...

Page 93: ...d 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 de...

Page 94: ...tart 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...

Page 95: ...red the best The one with the best FVC is considered the best The one with the best FEV1 is considered the best The curves with warnings ET EX are considered the worst 5 As a guideline for subsequent...

Page 96: ...conds RELEASE THE KEYS You should then release keys and The spirometer is now in HOSPITAL mode DISPLAYING SAVED INFORMATION The information saved can be displayed on the DATOSPIRMICRO spirometer or on...

Page 97: ...Chapter 3 Models B and C Operation DATOSPIR MICRO User s Manual 97 511 A00 MU2 REV 2 06 3 MODELS B AND C OPERATION...

Page 98: ...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 alpha...

Page 99: ...here Temperature Start of the spirometric manoeuvre Graph presentation Flow Volume only in FVC Volume Time Manoeuvre selection Select the best manoeuvre Manoeuvre data selected Memory for five manoeuv...

Page 100: ...Standard Configuration Retrieving the configuration Saving the configuration Patient mode customisation Patient and test data Database customisation Number of registers Common Customisation Setting t...

Page 101: ...PRE and POST Difference between PRE and POST Printout of warnings of Non Compliant manoeuvres with ATS ERS criteria Equipment protection customisation Modifying the pin MAINTENANCE Warning selection...

Page 102: ...pter 3 Models B and C Operation DATOSPIR MICRO User s Manual 102 511 A00 MU2 REV 2 06 DILATION Carrying out Post bronchial dilation test REPORT Printing a report BLUETOOTH Enabling or disabling Blueto...

Page 103: ...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 me...

Page 104: ...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 paramet...

Page 105: ...s with ATS ERS criteria Date of latest calibration CUSTOMISATION OF THE PATIENT MODE In this option it is possible to configure the DATOSPIR MICRO for use in patient mode See section 3 13 PATIENT MODE...

Page 106: ...options Patient mode customisation Database customisation Common customisation Spirometry customisation Protection customisation as described in this section 2 Go back to the Standard Configuration op...

Page 107: ...lock time and date or 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 langua...

Page 108: ...quipment 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: ...C Operation DATOSPIR MICRO User s Manual 109 511 A00 MU2 REV 2 06 DATABASE CUSTOMISATION This option allows you to choose the number of registers to be advanced if performing a fast advance using the...

Page 110: ...t 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 If an erroneous P...

Page 111: ...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...

Page 112: ...cription 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...

Page 113: ...garettes 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 s...

Page 114: ...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: ...report Pressing on the graph area makes the buttons disappear and makes it larger or smaller or Makes the graph larger or smaller Pressing on the reference area top part of the screen accesses the pat...

Page 116: ...PIROMETRY TECHNIQUE Patients can carry out the spirometry manoeuvres in two different ways The first consists in starting the manoeuvre with FORCED EXPIRATION followed by FORCED INSPIRATION if require...

Page 117: ...ow 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...

Page 118: ...ed 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 of the FVC or 0 15...

Page 119: ...red is worse than the five saved and will be deleted If three or more manoeuvres have been completed and the FVC and or FEV1 signs are flashing this indicates that the repeatability criterion for one...

Page 120: ...noeuvre Display the diagnosis of the selected manoeuvre Print the report on the selected manoeuvre Save the selected manoeuvre in the database or Display the remaining parameters if selected The scree...

Page 121: ...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 ha...

Page 122: ...ence Normal Diagnosis If FEV1 FVC FEV1 FVC Reference and FEV1 80 of the FEV1 Reference Obstructive ventilatory defect FEV1 80 Slight FEV1 65 Moderate FEV1 50 Intense FEV1 35 Very Intense If FEV1 FVC F...

Page 123: ...fect 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 diagnos...

Page 124: ...which are subsequently transferred to a PC Database This base may be of the L or H depending on its capacity The manoeuvre selected by default is the best M1 If you want to save another it must first...

Page 125: ...r 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 h...

Page 126: ...flashing from the test screen and press The best M1 is recommended The following screen will then appear to indicate the printing process The printer will present a report similar to the one shown on...

Page 127: ...Chapter 3 Models B and C Operation DATOSPIR MICRO User s Manual 127 511 A00 MU2 REV 2 06 U...

Page 128: ...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 selecte...

Page 129: ...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 de...

Page 130: ...een and perform a manoeuvre 2 The axes are always displayed in VOLUME TIME mode 3 Instruct the patient as to how to the test is being carried out as his cooperation is vital for it to be completed cor...

Page 131: ...Chapter 3 Models B and C Operation DATOSPIR MICRO User s Manual 131 511 A00 MU2 REV 2 06 U...

Page 132: ...s the MVV test by pressing the key from the main screen and perform a manoeuvre 2 The axes are displayed in VOLUME TIME mode 3 Instruct the patient as to how to the test is being carried out as his co...

Page 133: ...Chapter 3 Models B and C Operation DATOSPIR MICRO User s Manual 133 511 A00 MU2 REV 2 06 U...

Page 134: ...of applying a bronchial dilating drug in the same report The procedure to carry out Post bronchial dilating Spirometry is as follows 1 Complete a FVC VC or MVV test on the patient before applying the...

Page 135: ...2 06 Using keys and the VC and MVV tests can be seen respectively saved in PRE mode 5 Select the PRE test with which it is to be compared and press The screen then shows the two graphs PRE and POST fo...

Page 136: ...son between them depending on the option selected in customisation See section 3 2 EQUIPMENT COSTUMIZATION Weighted between PRE and POST between REF and POST between PRE and POST Difference between PR...

Page 137: ...Chapter 3 Models B and C Operation DATOSPIR MICRO User s Manual 137 511 A00 MU2 REV 2 06 U...

Page 138: ...this calibration factor must take the changes in volume associated to atmospheric conditions temperature relative humidity and barometric pressure into account The most influential factor is temperatu...

Page 139: ...ata Volume volume of the syringe between 0 and 6 litres depending on the syringe If a 0 is entered the default factors are used Fct 1 and NPulses 188 and the calibration process is completed No of Pul...

Page 140: ...lthough 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 C det...

Page 141: ...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 u...

Page 142: ...calibration factors EXP F and INS F 1 00 corresponding to original factory calibration This calibration should only be used as a guideline and in the event of no syringe being available CALIBRATION R...

Page 143: ...3 511 A00 MU2 REV 2 06 Deletes a register Prints existing registers and Moves around the different calibrations The information shown is Number of registers available Date of calibration Time of calib...

Page 144: ...is unplugged 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 1...

Page 145: ...5 511 A00 MU2 REV 2 06 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 Press to access the screen with the...

Page 146: ...11 A00 MU2 REV 2 06 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 bac...

Page 147: ...ted Displays the test selected and 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...

Page 148: ...t 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 messag...

Page 149: ...ess 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 prin...

Page 150: ...IR MICRO User s Manual 150 511 A00 MU2 REV 2 06 DELETE DATABASE Select the option to delete the database The following message will appear Press to accept and delete the database or press to go back t...

Page 151: ...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 th...

Page 152: ...k 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...

Page 153: ...er s Manual 153 511 A00 MU2 REV 2 06 Go back to the previous screen Black background white content White background black content Validate choice and Increase decrease contrast EQUIPMENT CHECK Select...

Page 154: ...d Check that the automatic on and off work properly Upon selecting this option the equipment switches off and on automatically after 5 seconds Display the values of different variables No pulses Turbi...

Page 155: ...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...

Page 156: ...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 u...

Page 157: ...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 th...

Page 158: ...n 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...

Page 159: ...he 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...

Page 160: ...are 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...

Page 161: ...est 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 equ...

Page 162: ...ails 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 x...

Page 163: ...trolled 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 T...

Page 164: ...2 REV 2 06 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 fo...

Page 165: ...ialist 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 follow...

Page 166: ...MU2 REV 2 06 and the equipment will issue a beeping sound every 10 seconds If for 2 minutes the equipment is not pressed it will switch off Press the key 2 The following screen will appear The patien...

Page 167: ...o the following criteria The one with the best sum of FVC FEV1 is considered the best The one with the best FVC is considered the best The one with the best FEV1 is considered the best The curves with...

Page 168: ...Chapter 3 Models B and C Operation DATOSPIR MICRO User s Manual 168 511 A00 MU2 REV 2 06 HIGH To do so press to go to the next screen or...

Page 169: ...ICRO User s Manual 169 511 A00 MU2 REV 2 06 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...

Page 170: ...ll 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 dis...

Page 171: ...Chapter 4 Communications system DATOSPIR MICRO User s Manual 171 511 A00 MU2 REV 2 06 4 COMMUNICATIONS SYSTEM...

Page 172: ...d 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 tha...

Page 173: ...Connect the equipment and the PC by series port USB or Bluetooth 3 Run the previously installed W 20 Spirometry Software making sure that the DATOSPIR MICRO is selected in Configuration Links and acc...

Page 174: ...ant 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...

Page 175: ...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...

Page 176: ...Chapter 4 Communications system DATOSPIR MICRO User s Manual 176 511 A00 MU2 REV 2 06 4 4 SPIROMETRY SOFTWARE W 20 FOR PC See the W 20 Spirometry Software User s Manual for all related information...

Page 177: ...Chapter 5 Technical Specifications DATOSPIR MICRO User s Manual 177 511 A00 MU2 REV 2 06 5 TECHNICAL SPECIFICATIONS...

Page 178: ...al Capacity FEV 5 l Forced Expirometry Volume in 0 5 seconds FEV1 l Same in 1 second FEV3 l Same in 3 seconds FEV 5 FVC Ratio FEV1 FVC Ratio FEV3 FVC Ratio FEV1 VC Ratio PEF l s Flow Apex FEF75 l s Ma...

Page 179: ...rced Expirometry Volume in 6 seconds FEV1 FEV6 Ratio EPOC rate Parameter that depends on the number of cigarettes smoked a day the age and FEV1 Indicates the risk of EPOC Age of the Lung Parameter tha...

Page 180: ...CITY Parameters VC l Slow vital capacity TV l Tidal volume ERV l Expiratory Residual Volume IRV l Inspiratory Residual Volume IC l Inspiratory Capacity Ti s Inspiratory time Te s Expiratory time Tt s...

Page 181: ...ted 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 DI...

Page 182: ...tion Customisation of the language printer and report heading etc Spirometry customisation Parameters of reference Observed parameters Graph selection Diagnosis selection Report customisation INTERNAL...

Page 183: ...tion Rotation is made on saphire bearings for high reproduceability and duration RANGES AND MEASUREMENTS Turbine Measurement Scale BTPS Flow l s 0 to 16 Volume l 0 to 10 Dynamic flow resistance cmH2O...

Page 184: ...ve MVV curves with a maximum of 15 seconds each Start FVC expiration Using the retrograde extrapolation method End FVC expiration When the volume accumulated in the last second is below 0 025 litres F...

Page 185: ...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 Mod...

Page 186: ...and 40 C Power supply 1 5 V battery alkaline recommended or 1 2 NiMh battery recommended 2200mAh Power Below 400 mW Size 153 5 x 80 x 52 mm Weight 250 g Useful life Device 7 years Turbine up to 1400 d...

Page 187: ...eters for measuring forced expiratory volume during a time interval in humans EN ISO 23747 2015 Spirometers for peak expiratory flow Recommendations SERIES ATS ERS TASK FORCE No 1 Miller MR Crapo R Ha...

Page 188: ...10 Biological evaluation of medical devices Part 1 SOFTWARE EN 62304 2006 AC 2008 A1 2015 Software for Medical Devices DOCUMENTATION AND INFORMATION EN 1041 2008 Information supplied by the manufactur...

Page 189: ...71 2012 Risk management in medical equipment WASTE RD 110 2015 Electrical and electronic equipment and waste management Transposition of WEEE 2012 19 UE Directive 3 To be satisfied by the user DATA PR...

Page 190: ...RO User s Manual 190 511 A00 MU2 REV 2 06 5 6 1 SIMBOLOGY SERIAL NUMBER MANUFACTURER The date of manufacture name and address of manu facturer TEMPERATURE LIMITATION HUMIDITY LIMITATION PREASURE LIMIT...

Page 191: ...Technical Specifications DATOSPIR MICRO User s Manual 191 511 A00 MU2 REV 2 06 DISPOSAL OF WASTE ELECTRICAL ELECTRONIC AGREEMENT TO THE WEE DIRECTIVE DO NOT REUSE START UP STANDBY BF APPLIED PART B AP...

Page 192: ...Chapter 5 Technical Specifications DATOSPIR MICRO User s Manual 192 511 A00 MU2 REV 2 06...

Page 193: ...Chapter 6 Operating Principles DATOSPIR MICRO User s Manual 193 511 A00 MU2 REV 2 06 6 OPERATING PRINCIPLES...

Page 194: ...ith 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 operate...

Page 195: ...n 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 ou...

Page 196: ...ler 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...

Page 197: ...00 MU2 REV 2 06 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 pr...

Page 198: ...Chapter 6 Operating Principles DATOSPIR MICRO User s Manual 198 511 A00 MU2 REV 2 06...

Page 199: ...Chapter 7 Spirometry Technique DATOSPIR MICRO User s Manual 199 511 A00 MU2 REV 2 06 7 SPIROMETRY TECHNIQUE...

Page 200: ...ximately 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 observati...

Page 201: ...ric 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...

Page 202: ...nd 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 Hen...

Page 203: ...es Age 6 20 20 70 FVC 1 9 2 2 FEV1 2 2 2 2 FEF25 75 6 5 4 8 FEF50 FVC 5 3 4 7 Values corresponding to 33 healthy volunteers Values from 20 healthy adults According to ATS ERS standardisation parameter...

Page 204: ...6 0 811 F 0 046T 0 067E 4 17 0 803 0 669 FEF 75 FVC M 0 024T 0 066E 2 61 0 760 0 562 F 0 027T 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 04...

Page 205: ...9 0 43 0 71 FEV1 M 4 30H 0 029A 2 49 0 51 0 84 F 3 95H 0 025A 2 60 0 38 0 62 FEV1 FVC M 0 18A 87 21 7 17 11 80 F 0 19A 89 10 6 51 10 70 FEF 25 75 M 1 94H 0 043A 2 70 1 04 1 71 F 1 25H 0 034A 2 92 0 85...

Page 206: ...nce for certain groups of the population This factor ranges from 80 to 120 of the values of reference where 100 is the value according to each table 7 5 OTHER VALUES OF REFERENCE Based on Separ and Ce...

Page 207: ...DATOSPIR MICRO User s Manual 207 Chapter 8 Upkeep Preventative and Corrective Maintenance 511 A00 MU2 REV 2 06 8 UPKEEP PREVENTATIVE AND CORRECTIVE MAINTENANCE...

Page 208: ...owledge 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 th...

Page 209: ...ollow 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...

Page 210: ...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 U After Sales Service or your distributor to review or repai...

Page 211: ...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 U 8 3 CORRECTIVE MAINTENANCE Corrective maintenan...

Page 212: ...DATOSPIR MICRO User s Manual 212 Chapter 8 Upkeep Preventative and Corrective Maintenance 511 A00 MU2 REV 2 06...

Page 213: ...Appendix 1 Electromagnetic Compatibility DATOSPIR MICRO User s Manual 213 511 A00 MU2 REV 2 06 APPENDIX 1 ELECTROMAGNETIC COMPATIBILITY...

Page 214: ...e user should assure that it is used in such an environment Emissions test Compliance Electromagnetic environment Gui dance RF Radiated emissions CISPR 11 EN 55011 Grupo 1 Clase B RF Conducted emissio...

Page 215: ...ical fast transient burst EN IEC 61000 4 4 2 kV for power supply lines and earth 1 kV for input output lines Frecuency 100 kHz Not applicable Not applicable DATOSPIR MICRO works with batteries The inp...

Page 216: ...level Electromagnetic environment guidance Electrostatic discharge ESD EN IEC 61000 4 2 8 kV contact 2 4 8 15 kV air 8 kV contact 2 4 8 15 kV air Radiated RF EN IEC 61000 4 3 3 V m 80 MHz to 2 7 GHz 8...

Page 217: ...y MHz Band MHz Modulation Power W Distance m E V m 385 380 390 Pulso 18Hz 1 8 0 3 27 450 430 470 FM D 5kHz 1kHz sinus 2 0 3 28 710 745 780 704 787 Pulso 217Hz 0 2 0 3 9 810 870 930 800 960 Pulso 18Hz...

Page 218: ...Appendix 1 Electromagnetic Compatibility DATOSPIR MICRO User s Manual 218 511 A00 MU2 REV 2 06...

Page 219: ...Appendix 2 Compliance with the Data Protection Act DATOSPIR MICRO User s Manual 219 511 A00 MU2 REV 2 06 APPENDIX 2 COMPLIANCE WITH THE DATA PROTECTION REGULATIONS...

Page 220: ...in force the user is the only party responsible for saving and processing the data of his patients according to the Law The observance of the recommendations included in this section does not guarante...

Page 221: ...per 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...

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