SPIROMETER DATOSPIR 600
Contents
1. In any case SIBEL S A as the manufacturer must authorize in writing at least during the warranty period the correspon ding technical service allowing them to perform such mainte nance In any case no responsability for damage misfunction etc will be admitted which might arise as a result of a defective maintenance by persons not belonging to SIBEL S A The Spirometry Software DATOSPIR 600 does not require any specific maintenance except the one for any computer pro gram which manage information Make a copy in a floppy disk or other supports in case the ori ginal is damaged Make periodical back up copies in the Data Bases used so as to restore them if any piece of information is lost in the compu ter Instructions Sibelmed Spirometer DATOSPIR 600 60 If any problem doubt or suggestion appear before during or after the use of the device it is recommended to follow these steps 1 Use the helps available in the program 2 Consult this User Manual 3 Contact the Aftersales Service of SIBEL S A SIBEL S A Rossell 500 08026 BARCELONA SPAIN SERVICIO POSTVENTA Tel 34 93 433 54 50 FAX 34 93 436 16 11 e mail sat sibelmed com 5 3 CORRECTIVE MAINTENANCE The corrective maintenance consists of keeping the device in a good condition of use which has been put out of service due to bad operation or use and which is necessary to repair In case of detecting in the system a breaak down whic2. The spirometer DATOSPIR 600 belongs to CLASS IIa accor ding to the criteria of Medical Products European Directive 93 42 CEE and according to the type of protection against electrical shock hazard the norm EN60601 1 the classification for the device is CLASS I type B The spirometer DATOSPIR 600 works as standard through an external power supply connected to a main electrical supply of 511 900 MU2 e REV 2 02 SUOIPNAZSUI Instructions Sibelmed Spirometer DATOSPIR 600 200 to 240 V 50 60 Hz with earth connection under demand of 100 to 130 V 50 60 Hz The link of data between the device and the computer is optica Ily isolated The computer connected to the device must meet the requi rements of electric safety for this type of devices IEC950 EN60601 etc The maximum power required including the calefactor of the neumotachometer Fleisch is under 25 VA The environment conditions for properly operation are Temperature 109 to 409C The American Thoracic Society recommends 17 to 40 C Humidity lower than 85 without condensation Atmospheric pressure from 525 to 800 mmHg from 3000 to 400 metres approx The power supply cable includes the protection conductor as the spirometer has to be connected to the ground like every electromedical device of the CLASS I according to EN60601 1 Do not place the device close to water or other liquid sources Do not cover the device with objects which can prevent the
3. Graphics paediatric motivation and language Data Bases Communication Links with the Software 511 900 MU2 e REV 2 02 SUOIPNIAZSUI Instructions Sibelmed Spirometer DATOSPIR 600 2 2 8 DATA BASE Possibility to work with different Data Bases Storing of espirometric tests in FVC VC MVV or Postbroncho dilation mode Storing of tests Creation deletion modification in the patient cards Fast consult in the base by Record Reference Surname Printing Reports from the data base 2 3 MEASUREMENT SYSTEM 2 3 1 TRANSDUCER TYPES Transducer Fleisch type linearized by software and detachable for its cleanness and sterilization Diferential manometer of se miconductor type with internal compensation in temperature Transducer turbine type volumetric bidirectional of axial type with turn optoelectronic sensor detachable for its cleanness and sterilization The rotation is performed over zaphir shafts in or der to have a high reproductibility and duration Disposable transducer linearized by software and individua lly calibrated for one use applications Diferential manometer of semiconductor type with internal compensation in temperature 2 3 2 MEASUREMENT RANGE Fleisch Turbine Disposable Measurement Scale Flow l s Qa t i6 0a 16 0a 16 Volume l 0a 10 0a10 0 a 10 Dynamic resistance to the air flow kPa l s 0 03 lt 0 06 lt 0 06 Measurement Accuracy Volume the highest 3
4. MORRIS AUSTRIACAS GUTIERREZ CHILE BRASILENAS POLGAR WENG HATKINSON PEREZ PADILLA MEJICO Otras opcionales Ethnic Factor for Reference values Patient Identification Data Environmental Data temperature pressure and relative hu midity Graphics in FLOW VOLUME and VOLUME TIME mode Graphics for motivation in paediatric tests Concordance Manoeuvre Warnings with the ATS criteria 511 900 MU2 e REV 2 02 SUOIPNAZSUI Instructions Sibelmed Spirometer DATOSPIR 600 28 2 2 2 SLOW VITAL CAPACITY Parameters VC I Slow Vital Capacity TV 1 Tidal Volume ERV Il Espiratory Reserve Volume IRV I Inspiratory Reserve Volume IG I Inspiratory Capacity Ti s Inspiratory Time Te s Espiratory Time Tt s Total Time Ti Tt Relation Normalized Reference Parameters to be selected among diffe rent standards Ethnic Factor for Reference values Patient Identification Data Environmental Data temperature pressure and relative hu midity Graphics in VOLUME TIME mode 2 2 3 MAXIMAL VOLUNTARY VENTILATION Parameters MVV l min Maximal Voluntary Ventilation Br min Br min Breathing Frequency of MVV Normalized Reference Parameters to be selected among diffe rent standards Ethnic Factor for Reference values Patient Identification Data Environmental Data temperature pressure and relative hu midity Graphics in VOLUME TIME mo
5. metry variability prevents the detection of small differences in volume and flow measurement see chart I In normal working conditions calibration by means of volume signal provided by a hand syringe must be carried out daily The signal provided by the syringe must be produced with diffe rent thrusts in order to verify that the flow read out maintains a rectilinear response The machine must integrate the signal always in the same volume i e the volume provided by the syringe signal no matter how sudden the injecting operation may be as long as it does not surpasses the upper limit of flow rank accurately measured by the machine itself proximity to actual value The calibration with dynamic gauged signal provided by the ex plosive decompressor or espirometry measurement in control individuals mentioned above cannot be performed so often As for tachometers it is advisable to carry it out with the decom pressor once a fortnight As espirometries with control indivi duals are more complicated and less available it cannot Sibelmed Spirometer DATOSPIR 600 49 be performed more often than once a month unless you sus pect a malfunction Chart 1 Variability of the espirometry in a healthy person Coeficiente de variaci n Yo MEF 50 FVC Variables Age 6 20 years Age 20 70 years FVC 1 9 2 2 FEV 4 2 2 2 2 FEF 25 75 6 5 4 8 5 3 4 7 Values corresponding to 33 healthy
6. 0 15 1 21 1 99 F 5 50H 0 0304 1 11 0 90 1 48 MEF75 FVC M 5 46H 0 029A 0 47 1 71 2 81 F 3 22H 0 025A 1 60 1 35 2 22 MEF50 FVC M 3 79H 0 031A 0 35 1 32 2 17 F 2 45H 0 025A 1 16 1 10 1 81 MEF25 FVC M 2 61H 0 026A 1 34 0 78 1 28 F 1 05H 0 025A 1 11 0 69 1 13 M Male F Female H high m A age years RSD Residual Standard Deviation Between 18 and 25 years 25 is computed for all references IMPORTANT NOTE A ETHNIC FACTOR can be introduced in the DATOSPIR 600 Spirometer This factor modifies the reference va lues for different population groups It can be in the ran ge from 75 to 110 of the reference values being a 100 the value of the tables 511 900 MU2 e REV 2 02 SUOIPNAZSUI Instructions Sibelmed Spirometer DATOSPIR 600 52 4 5 TECHNIQUE OF MEASUREMENT AND REFERENCE VALUES The maximal inspiratory pressure PImax depends directly on the strength developed by the inspiratory muscles Its measure ment is very useful in the diagnosis and follow up of patients with neuro muscular illnesses specific alterations of the respiratory muscles different processes of the thoracic area air trapping or modifications produced by breath depressive medicines among other clinic situations The maximal espiratory pressure PEmax also informs about the cough efficacy and the drainage of the bronchial secretions In both cases they are measures easy to performe and comfort
7. 1 PROCEDURE The following is an extract from NORMATIVA PARA LA ES PIROMETRIA FORZADA FORCED SPIROMETRY REGULATIONS SEPAR recommendations N 1 Forced spirometry must be performed by the patient sitting bolt upright having his nose blocked by nose clips The techni cian must lean his hand against the patient s shoulder to pre vent the patient leaning forward during espiration time The mouthpiece must be crushproof in order to avoid artefacts cau sed by the reduction of light due to bite during forced espira tion Soft mouthpieces must be shortened in order to increase its consistency The spirometry will always involve a minimum of three forced espiration manoeuvres and a maximum of eight if they are not considered suitable Surpassing this limit will mean pointless patient tiredness and a loss of time for the technician For the evaluation of the spirometry performed in decubitus position you must bear in mind that the obtained data under these conditions are approximately 10 lower than the data ob tained with the patient sitting In patients with diaphragmatic or neuromuscular pathology the difference between both positions can be 40 60 which makes the observation a useful piece of information to evaluate the repercussion of this pathology When you work with the pneumotachometer the manoeuvre can be reduced exclusively to the maximum espiration in the position of maximum inspiration The accuracy
8. RISKS OF CONTAMINATION Fleisch and Turbine Transducers To avoid risks of contamination or crossed infection the turbine and the Fleisch neumotacho 511 900 MU2 e REV 2 02 A19jes Safety Sibelmed Spirometer DATOSPIR 600 8 meter must be disinfected following this manual s instructions and its mouthpieces must not be reutilized Disposable Transducers It must not be reutilized each new one must be used for each new patient The use of mouthpieces or any other consumibles of the product manufactured with improper materials that can compromise their biocompatibility must be avoided RISK OF INTERFERENCE This is an electronic product so high frequency emissions can interfere with the correct use For this reason the products which can generate interferences radios cellular phones etc should be kept apart The portable or mobile radiofrequency devices can affect the normal functioning 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 infor mation attached See Appendix 1 ELECTROMAGNETIC COMPA TIBILITY The use of transducers accessories and cables different to the ones specified here except the transducers and cables sold by the manufacturer as spare parts could adversely affect patient safety cause a malfunction of the equipment and or prod
9. determined by surpassing the minimum level of air flow approximately 100 ml although immediately previous values are not discarded Retrograde extrapolation The determination of the FVC manoeuvre start is made through the retrograde extrapolation according to the A T S and S E P A R criteria Identification of the espiration end The end of the manoeuvre is made according to the A T S criteria that is when the volume 511 900 MU2 e REV 2 02 Sibelmed Spirometer DATOSPIR 600 45 accumulated in the last second is lower than 30 ml Calibration program Turbine The accumulated dirty or possible wear of the turbine trans ducer could result in an inaccurate measurement In order to check that the turbine measures correctly the system includes a simple verification procedure based on measuring the known volume of a calibration syringe Neumotachometers The relation between the pressure and flow drops in the neu motachometers depends on the gas viscosity This viscosity de pends on the weather conditions of temperature pressure and humidity For this reason it is necessary to calibrate the neumo tachometer every day or every time that the weather conditions change By analysing the relative importance of each factor the most influent one is the temperature followed by the humidity degree 511 900 MU2 e REV 2 02 suononajsum Instructions Sibelmed Spirometer DATOSPIR 600 46 4 SPIROMETRY TECHNIQUE 4
10. into the no 8 jack on the device WARNINGS Do not twist unnecessary or use excessive force when using connecting disconnecting or storing the finger sensor suononajsu Instructions Sibelmed Spirometer DATOSPIR 600 24 Misuse or improper handling of the sensors may cause damage to the sensor or to the cable This would cause incorrect measu rements and readings 2 Select a suitable site for the sensor The first finger index is the preferred location Alternative sites recommended are the thumb little finger or the large toe A FA LE Pak d 3 Insert the finger right to the end of the sensor to get accurate measurements The fingernail must be kept pointing toward the upper part of the sensor and the cable must be positioned along the top of the hand or food WARNING Ensure that long fingernails do not interfere with the pro per positioning of the finger or with sensor function Re move nail polish or artificial acrylic nails before placying the SpO2 sensor as this can cause incorrect readings 4 To obtain the best results especially during long term studies 8 hours approx fasten the cable separately from the sensor using surgical tape preferably around the base of the finger see the figure above Make sure that the tape fastening the cable does not restrict blood circulation 511 900 MU2 e REV 2 02 Sibelmed Spirometer DATOSPIR 600 25 WARNING For log term monitoring is recommend
11. station o oO O O O Module of SpO2 eere enne O N Instructions Sibelmed Spirometer DATOSPIR 600 12 Module of PIM PEM rennen nnne 0 oO O This product is manufactured under strict quality controls Ne vertheless accidents may 1 3 happen in the transport or storage so it is convenient to make a status check before installing it as well as of its accessories 511 900 MU2 e REV 2 02 Sibelmed Spirometer DATOSPIR 600 13 SPIROMETER DATOSPIR 600 USER S MANUAL Sibelmed 7 511 900 MU2 e Rev 2 02 e 2013 10 511 900 MU2 e REV 2 02 suonon nsur Instructions Sibelmed 7 Spirometer DATOSPIR 600 14 511 900 MU2 e REV 2 02 Sibelmed Spirometer DATOSPIR 600 15 RESPONSABILITY OF THE MANUFACTURER SIBEL S A is responsible for the safety reliability and functio ning of this device only if The place where the device is and the computer where the software is installed meets the requirements related to electrical installation IEC UNE for medical devices as well as the other applicable norms The repairs checks or modifications in or out the wa rranty period are performed by technical staff at SIBEL S A The use of the software and the recommendations of use are made by qualified staff according to the User s Manual 511 900 MU2 e REV 2 02 SUOIPNAZSUI Instructions Sibelmed Spirometer DATOSPIR 600 1 3 DISTRIBUTION OF CON
12. volunteers Values of 20 healthy adults 4 3 REFERENCE VALUES FOR FORCED SPIROMETRY SEPAR The DATOSPIR 600 spirometer incorporates the tables of refe rence of the SEPAR that can be selected by means of the Setup Program paragraph 1 8 Next the equations corresponding to the SEPAR and ECCS 93 reference values are presented If you are interested in some other tables request it to SIBEL S A 511 900 MU2 e REV 2 02 SUOIPNAZSUI Instructions Sibelmed Spirometer DATOSPIR 600 Parameter Sex Ecuation 6 20 years R SEE FVC M 0 02800T 0 03451P 0 05728E 3 21 0 947 0 947 F 0 03049T 0 02220P 0 03550E 3 04 0 935 0 313 FEV1 M 0 02483T 0 02266P 0 07148E 2 91 0 945 0 378 F 0 02866T 0 01713P 0 02955E 2 87 0 940 0 263 FEV1 FEVC M 0 593E 0 113P 81 60 F 0 026T 82 60 FEF25 75 M 0 038T 0 140E 4 33 0 832 0 796 F 0 046T 0 051E 4 30 0 789 0 651 PEF M 0 075T 0 275E 9 08 0 907 1 073 F 0 073T 0 134E 7 57 0 879 0 831 MEF50 FVC M 0 017T 0 157E 0 029P 2 17 0 856 0 811 F 0 046T 0 067E 4 17 0 803 0 669 MEF25 FVC M 0 024T 0 066E 2 61 0 760 0 562 F 0 027T 0 032E 2 68 0 709 0 507 Parameter Sex Ecuation 20 70 years R SEE FVC M 0 0678T 0 0147E 6 05 0 72 0 530 F 0 0454T 0 0211E 2 83 0 75 0 403 FEV1 M 0 0499T 0 0211E 3 84 0 75 0 444 F 0 0317T 0 02
13. with air at room temperature 5 Assemble the turbine in the housing again Fig 5 5 If a microbian contamination is suspected it is necessary to use 511 900 MU2 REV 2 02 suonon vsuT Instructions Sibelmed Spirometer DATOSPIR 600 58 antiseptics in solution or more complex sterilizing procedures for example the immersion in a solution of Dietilentramine or Sodium Dichloroisocianurate for 10 or 30 minutes P RECAUTION DO NOT EXPOSE THE TURBINE AT TEMPERATURES EX CEEDING 60 C OR BELOW 0 C DO NOT USE SOLVENTS ALCOHOLS OR SIMILAR SUBSTANCES IT DURING ITS CLEANING WHICH CAN DAMAGE IT C Maximal pressure transducer The shutter probe can be washed with soap or some disinfectant liquid which does not chemically attack the methacrylate or Te flon of the composition After the rinse and drying of the probe lubricate the friction space between the probe and the cursor with Vaseline Finally check that the components are not obstructed and that it works correctly 5 1 2 SPIROMETER The spirometer is smoothly wiped with a dry or slightly water moistened cloth drying thereafter the remanent humidity Take care that no liquid penetrates inside or in the connectors or connections Do not use abrasive substances or solvents 5 2 PREVENTIVE MAINTENANCE The preventive maintenance consists of all those technical ac tion
14. 1 900 MU2 e REV 2 02 Sibelmed Spirometer DATOSPIR 600 48 This is not always possible but at least some of the biological signal elements such as volume and flow should be reproduced either together or separately For this purpose syringes with a capacity of several litres provide a suitable signal and flow ge nerators are good for evaluating the accuracy and errors in the flow measurament The so called explosive descompressor is one of the most practical calibration machines It consists of a chamber of 4 or 5 litres pressured at 1 atmospher provided with a sudden opening for the violent expulsion of a volume which is identical to the volume inside the chamber In this way an individual s forced espiration can be simulated By placing sui table resistances with different obstruction rate in the exit tube the signal is similar to that of a patient with slight moderate or severe obstruction to air flow Therefore it checks both the volume and the flow measurements If this cannot be achieved you can check the machine operating conditions by means of using control individuals that is to say people connected with the laboratory who are willing to cooperate They can perform a correct espirometry easily and with little variability chart I in such a way that they can reproduce their espirometry periodica lly and compare it to previous data In this way errors that are necessarily of a large magnitude can be detected The espiro
15. 3 161 No 2 Miller MR Hankinson J Brusasco V et al Standardisation of spirometry Eur Respir J 2005 26 319 338 No 3 V Brusasco R Crapo and G Viegi Standardisation of the Measurement of lung volume Eur Respir J 2005 26 511 522 e Sanchis et al Regulations for spirometry No SEPAR recom mendations 1 Arch Bronconeumol 1989 25 132 142 PULSE OXIMETRY for devices with oximetry option e EN ISO 9919 2009 General requirements for basic safety and essential performance for medical pulse oximetry USABILITY AND APTITUDE FOR USE e EN 60601 1 6 2010 General requirements for safety Part 1 6 Collateral standard Usability e EN 62366 2008 Application of engineering skills to use medi cal devices VIBRATION AND TEMPERATURE e Series EN 60721 1995 Classification of environmental condi 511 900 MU2 e REV 2 02 Sibelmed Spirometer DATOSPIR 600 35 tions e Series EN 60068 1999 Environmental testing BIOCOMPATIBILITY e ISO 10993 1 2009 AC 2010 Biological evaluation of medical devices Part 1 SOFTWARE e EN 62304 2006 AC 2008 Software for Medical Devices DOCUMENTATION AND INFORMATION e EN 1041 2008 Information supplied by the manufacturer of medical devices e EN ISO 15223 1 2012 Graphical symbols for use in labeling in medical devices 2 Related to the manufacturer QUALITY e EN ISO 13485 2012 AC 2012 Quality management systems Requirements for regulatory purposes e EN ISO 9001 2008 quality managemen
16. 50E 1 23 0 82 0 307 FEV1 FEVC M 0 1902E 85 58 F 0 224E 0 1126P 94 88 FEF25 75 M 0 0392T 0 0430E 1 16 0 55 1 000 F 0 0230T 0 0456E 1 11 0 70 0 680 PEF M 0 0945T 0 0209E 5 77 0 47 1 470 F 0 0488T 0 0304E 0 35 0 47 1 040 MEF50 FVC M 0 0517T 0 0397E 2 40 0 47 1 300 F 0 0242T 0 0418E 1 62 0 56 0 925 MEF25 FVC M 0 0190T 0 0356E 0 14 0 63 0 620 F 0 02T 0 031E 0 0062P 0 21 0 76 0 405 FEV1 PEF M 6 64 F 7 77 FEV1 FEVO 5 M 1 45 F 1 50 MEF50 MIF50 M 0 66 F 0 88 PEF PIF M 1 39 F 1 42 FEV1 FIV1 M 0 80 F 0 89 M Male F Female R multiple correlation coefficient SEE typical estimation error T size cm P weight Kg E age years The parameters with an asterisk are not related in the referen ce standard of the SEPAR 511 900 MU2 e REV 2 02 Sibelmed Spirometer DATOSPIR 600 51 4 4 REFERENCE VALUES FOR FORCED SPIROMETRY ECCS 93 Standarized Lung Function Testing Official Statement of the Euro pean Respiratoy Society Luxembourg 1993 Parameter Sex Ecuation 18 70 years RSD 1 64RSD FVC M 5 76H 0 026A 4 34 0 61 1 00 F 4 43H 0 026A 2 89 0 43 0 71 FEV1 M 4 30H 0 029A 2 49 0 51 0 84 F 3 95H 0 025A 2 60 0 38 0 62 FEV1 FEVC M 0 18A 87 21 7 17 11 80 F 0 19A 89 10 6 51 10 70 FEF25 75 M 1 94H 0 043A 2 70 1 04 1 71 F 1 25H 0 034A 2 92 0 85 1 40 PEF M 6 14H 0 043A
17. IAZSUI Instructions Sibelmed Spirometer DATOSPIR 600 2 6 2 RANGES AND MEASUREMENTS Range of Measurement iind 300 Resolution cmH20 Accuracy Sample Rate Hz 100 2 6 3 CONTROL Number of manoeuvres Up to 5 manoeuvres for each type can be performed P max and Pimax Duration of the manoeuvres The maximum duration is 8 seconds Start of Manoeuvre When the threshold of 3 cmH O is surpassed End of Manoeuvre Variation lower than 1 cmH O in the last 2 seconds Delay in the calculation of the maximum pressure value Selectable in the setup between 0 1 and 4 9 seconds 1 second as a default Internal Data Base The Spirometer shares the internal data base for all test types 2 7 GENERAL DATA 2 7 1 TESTING AND PARAMETERS Datorpir 600 allows to perform short and long pulseoximetry measurements up to 8 hours Following parameters are calculated CT90 of the time that SpO2 is below 90 CT80 of the time that SpO2 is below 80 CT70 of the time that SpO2 is below 70 IDH 4 desaturation index gt 4 per hour IDH 3 desaturation index gt 3 per hour IDH 2 desaturation index gt 2 per hour SpO2 M xima SpO2 maximum value SpO2 Media SpO2 mean value SpO2 M nima SpO2 standard desviation 511 900 MU2 e REV 2 02 Sibelmed Spirometer DATOSPIR 600 33 SpO2Std desviaci n estandard de la Saturaci n PR M ximo valor m ximo de la frecuencia del pulso PR
18. Medio valor medio de la frecuencia del pulso PR M nimo valor m nimo del pulso PR Std desviaci n estandard del pulso Tiempo Prueba time of the test zero values are not taken into account 2 7 2 RANGES AND MEASUREMENTS Sp02 Pulso BPM Measurement range 20 100 25 250 Resolution 1 1bpm Accuracy 70 to 100x296 25 200 bpm 2bpm or 12 whichever is 60 to 69 3 greater 60 Unspecified 200 250 bpm 3bpm Response 8 seconds for 80 of 8 seconds for 80 of patient patient Perfusion rate 0 20 Digital Pleth Waveform Centered at 512 norm is 512 counts peak to peak 2 7 3 CONTROL Beginning and end of of the maneuver manually executed by the user Only one test is possible until a new patient is introduced When data is initialized it is allowed the beginning of a new study with the same patient 2 8 GENERAL DATA Applicable standards 1 Related to the product MEDICAL DEVICE 93 42 CEE Directive RD 1591 2009 511 900 MU2 e REV 2 02 suononajsum L Instructions Sibelmed Spirometer DATOSPIR 600 34 ELECTRICAL SAFETY e EN 60601 1 2006 AC 2010 Seg medical equipment Class I EMC electromagnetic compability e EN 60601 1 2 2007 AC 2010 EMC in medical equipment Not vital support See APPENDIX 1 ELECTROMAGNETIC COMPATIBILITY Recommendations e SERIES ATS ERS TASK FORCE No 1 Miller MR Crapo R Hankinson J et al General considerations for lung function testing Eur Respir J 2005 26 15
19. SPIROMETER DATOSPIR 600 USER S MANUAL Sibelmed 511 900 MU2 e Rev 2 02 e 2013 10 Sibelmed Spirometer DATOSPIR 600 3 CONTENTS 1 INSTRUCTIONS FOR USE AND INSTALLATION 1 1 INTRODUCTION 1 2 PREVIEW 1 3 DISTRIBUTION OF CONTROLS INDICATORS AND CONNECTORS 1 3 1 FRONT PANEL 1 3 2 RIGHT AND LEFT SIDE 1 3 3 BACK PANEL 1 3 4 STANDARD ACCESSORIES 1 3 5 OPTIONAL ACCESSORIES according to model 1 4 INSTALLATION AND SETUP 1 4 1 INSTALLATION 1 5 PULSIOXIMETER 1 6 CALIBRATION 1 7 UPDATING THE DEVICE SOFTWARE 1 8 TECHNICAL SUPPORT 2 TECHNICAL SPECIFICATIONS 2 1 SOFTWARE COMPATIBILITY 2 2 TYPES OF TESTS FUNCTIONS AND SPIROMETRIC PARAMETERS MEASUREMENT SYSTEM ANALYSIS CRITERIA ELECTRONIC WEATHER STATION MAXIMA PRESSURE MODULE PULSEOXIMETER MODULE GENERAL DATA SIMBOLOGY por II Ded in IA 3 FUNCTIONING PRINCIPLES 4 SPIROMETRY TECHNIQUE 5 PRESERVATION PREVENTIVE AND CORRECTIVE MAIN TENANCE 6 MODIFICATIONS ANNEX 1 ELECTROMAGNETIC COMPATIBILITY 511 900 MU2 e REV 2 02 S1uo1uo5 Revised Revised Date 2013 10 Date 2013 10 Antoni Pic Carlos Recio Technical Manager Sales Manager IN ACCORDANCE WITH 93 42 EEC Medical Devices Directive Il a Class SIBEL S A Rossell 500 08026 Barcelona Spain Ventas Nacionales Tel 93 436 00 08 email comercialOsibelmed com Ventas Internacionales International Sales Tel 34 93 436 00 07 email export sibelmed com Servicio T cnico T
20. TROLS INDICATORS AND CONNECTORS 1 3 1 FRONT PANNEL No 1 Functioning signal pilot 1 3 2 RIGHT AND LEFT SIDE No 2 Connection of spirometric transducer No 3 Connection of pulse oximetry sensor SpO2 No 4 Connection of the Maximal Respiratory Pressures transducer MIP MEP No 5 Board of characteristics 511 900 MU2 e REV 2 02 Sibelmed Spirometer DATOSPIR 600 17 TRANSDUCTOR TRANSDUCER C LEN MIP MEP 1 3 3 BACK PANNEL No 6 Serial communications port No 7 Connection of mains supply No 8 Additional Earth connection No 9 Housing for the Electronic Weather Station 511 900 MU2 e REV 2 02 SUOIPNAZSUI Instructions Sibelmed Spirometer DATOSPIR 600 18 5 RS 232 0 l et Jo o stico gano I O 1 3 4 STANDARD ACCESSORIES No 10 Disposable mouthpiece No 11 Nose clip No 12 User s Manual No 13 Mains supply No 14 Neumotachometer type Fleisch with holder No 15 Transducer with turbine No 16 Cable for data interconnection between DATOSPIR 600 and PC No 17 Disposable transducer 1 3 5 OPTIONAL ACCESSORIES depending on model No 18 Accessories option MIP MEP No 19 Accessories option pulse oximetry SpO2 No 20 Disposable transducer with holder No 21 Transport bag No 22 Calibration syringe 511 900 MU2 e REV 2 02 Sibelmed Spirometer DATOSPIR 600 19 1 4 INSTALLATION AND SETUP 1 4 1 INSTALLATION
21. The equipment must be stored and used within the temperatu re pressure and humidity ranges specified in this manual 511 900 MU2 e REV 2 02 Sibelmed Spirometer DATOSPIR 600 7 ELECTRICAL RISKS DO NOT alter the integrity of the system earth connection The protection against electrical hazards is provided by the chassis connection to the safety earth The safety earth con nection is only effective when the power supply cable of three wires provided with the device is plugged to an electrical soc ket properly connected to earth DO NOT remove the device or accessories cover Servicing and repair of the apparatus must only be carried out by trai ned personnel Contact with the voltage inside the system can cause serious injury DO NOT use damaged transducers accessories or cables DO NOT submerge the device parts in any liquid IT CAN RE SULT IN ELECTRICAL DISCHARGE DO NOT use multiple mains sockets unless they comply with EN 60601 1 They can degrade electrical safety ELECTRICAL DISCHARGE To ensure vital safety features under the EN 60601 1 standard only equipment compliant with the electrical safety standards in force may be connected to this device To connect DATOS PIR 600 to a non medical device with ground conductor you must install an additional ground conductor to the non medical device EXPLOSION RISKS DO NOT uses the device in presence of anaesthetics or flam mable gases IT CAN RESULT IN EXPLOSION
22. V3 I Idem in 3 seconds FEV 5 FVC Relation FEVI FVC 96 Relation FEV3 FVC Yo Relation FEVI VC 96 Relation PEF l s Peak Espiratory Flow MEF75 l s Maximal Espiratory Flow when the lung still has the 75 of FVC MEF50 l s Idem at 50 of FVC MEF25 l s Idem at 25 of FVC FEF25 75 l s Forced mesoespiratory Flow FEF75 85 l s Medium Flow between 75 85 of FVC FET25 75 s Time passed between 25 75 of FVC FET100 s Forced Espiratory Time MEF50 MIF50 Relation FEV1 FEV 5 Relation FEV1 PEF 96 Relation MIF50 l s Maximal Inspiratory Flow when 50 of FVC has been inspired FIVC I X Forced Inspiratory Vital Capacity FIV1 I Forced Inspiratory Volume in 1 second FIV1 FIVC 96 Relation FEV1 FIV1 96 Relation PIF l s Peak Inspiratory Flow 511 900 MU2 e REV 2 02 Sibelmed Spirometer DATOSPIR 600 27 MTT s Measured Transit Time PEF PIF Relation Vext Yo Extrapolated Volume related to FVC MVVin l min Maximal Voluntary Ventilation indirect 30 x FEV1 FEV6 1 Forced Inspiratory Volume in 6 seconds FEV1 FEV6 Relation 2 2 Indice EOPC Riesgo de contraer enfermedad de obstruc ci n de las v as a reas en los pr ximos 10 a os Edad del pulm n Seg n la referencia de Morris Diagnosis Miller Snider Kory amp Lyons Reference Parameters SEPAR CECA KNUDSON GRAPO ZAPLETAL
23. able for the patient They can be obtained near the patient and allow to follow his her evolution The procedure to obtain the PImax and the PEmax must com plete the following aspects Correct collaboration of the patient to get a maximum effort in the manoeuvres The patient must keep his her hands against the cheeks and leave them flaccid to attenuate the pressure ge nerated by the facial muscles To measure the PImax the patient must perform a deep ins piration from the position of Residual Volume and maintain the effort for at least 3 seconds To measure the PEmax the patient has to inspire previously up to the position of Total Pulmonary Capacity and from there blow with the maximum effort It is advisable a minimum of three satisfactory manoeuvres for each pressure If measuring errors are suspected we must make sure that the re are no leaks in the system and the correct collaboration of the patient in the maximum effort manoeuvres The Module of Maximal Pressures is useful for Pneumology Anaesthesiology ICU and Neurology units for isolated determi nationsor for the follow up of interned patients 511 900 MU2 e REV 2 02 Sibelmed Spirometer DATOSPIR 600 53 The device includes 4 different references to be selected by the user Next the bibliographic reference is detailed A P MORALES Presiones respiratorias est ticas m ximas en adultos Valores de referencia de una poblaci n caucasiana medi
24. air circulation during its functioning The sequence of operations to setup the DATOSPIR 600 in connection with the PC is the following 1 Connect the power supply output to the connection no 7 2 Put the power supply switch in position O OFF 3 Connect the power supply to the mains according to its volta ge and frequency as specified in the power supply and set the switch in position I START Light on Then the DATOSPIR 600 will emit a beep beep NOTE If you have purchased the pulseoximetry module the power supply will not have on off interruptor It will be only ne cessary to connect it to the power mains 4 Connect the transducer to the connector number 2 11 900 M 5 E OND U2 e REV 2 02 Sibelmed Spirometer DATOSPIR 600 21 5 Insert the mouthpiece in the transducer turbine or fleisch transducer or o disposable transducer in the disposable trans ducer handle WARNING The disposables transducers are individually pre calibrated and they have and asociated factor Therefore there is no need to carry out any calibration The factor must be introduced in the software so far the mea surement is performed correctly Before perform any test the check that the factor is the in the plastic bag and in the screen The factor can change from one bag to another but not inside the same If you purchase a new lot of disposable transducers remember to check and if necessary update the transducer fac tor If all
25. ality should be that of a typical commercial or hospital environ ment Voltage dips short in terruptions and volta ge variations on power supply input lines EN IEC 61000 4 11 lt 5 Ut gt 95 dip in Ut for 0 5 cycle 40 Ut 60 dip in Ut for 5 cycle 70 Ut 30 dip in Ut for 25 cycle lt 95 Ut gt 5 dip in Ut for 5 seconds lt 5 Ut gt 95 dip in Ut for 0 5 cycle 40 Ut 60 dip in Ut for 5 cycle 709 Ut 30 dip in Ut for 25 cycle lt 95 Ut gt 5 dip in Ut for 5 seconds Mains power quality should be that of a typical commercial or hospital environ ment Power frecuency 50 60 Hz magnetic field 3 A m 3 A m Power frequency magnetic fields should be at levels characteristic of a typical lo cation in a typical commercial of hospital environment Note Ut is the a c mains voltage prior to application of the test level 511 900 MU2 e REV 2 02 Sibelmed Spirometer DATOSPIR 600 Guidance and manufacturer s declaration electromagnetic immunity The Datospir 600 is intended for use in the electromagnetic environment specified below The customer or user should assure that it is used in such environment EN IEC 60601 Compliance Test Level Level Electromagnetic environment Guidance Immunity test Portable and mobile RF communications equi pment should be used no closer to any part of DATOSPIR 600 inclu
26. be found in the user s manual 511 900 MU2 REV 2 02 A19jes Safety Sibelmed Spirometer DATOSPIR 600 6 For more information consult SIBEL S A or your regular distri butor PATIENT S EFFECTS IN THE SPIROMETER USAGE Spirometry tests require the patient s collaboration the patient must perform a complete forced expiration to be able to get meaningful FVC values The doctor should assess the patient s capacity to perform the spirometry tests Special precaution must be taken with children elderly people and disabled people LIMITATIONS IN USE CONTRAINDICATIONS An spirometry test results analysis is not enough for itself to carry out an accurate diagnosis on the patient s clinical condi tion therefore it must be completed with the clinical history and those tests the doctor considers necessary The tests interpretation and the derived treatments must be performed by a doctor The patient s symptoms before the execution of any spirometry test must be considered by health care personnel Health care personnel is responsible of the acceptability of a test The spirometer must not be used when results validity might be probably compromised due to external factors Take care NOT to place the equipment where it could be splas hed by water or other liquids or cover it with objects that pre vent air from circulating around it while it is running The device should NOT be used stacked or adjacent to other equipment
27. bove the Datospir 600 should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocation the Datospir 600 511 900 MU2 e REV 2 02 SUOIPNAZSUI Instructions Sibelmed Spirometer DATOSPIR 600 Recommended separation distances between portable and mobile RF communication equipment and the Datospir 600 The Datospir 600 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or user of the Datospir 600 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communication equipment transmitters and the Datospir 600 as recommended below according to the maximum output power of the communi cations equipment Rated maximum output Separation distance according to frequency of transmitter power of transmitter 80 MHz to 800 MHz 800 MHz to 2 5 GHz Ww 0 01 0 12 0 23 0 1 0 37 0 74 1 1 17 2 33 10 3 69 7 38 100 11 67 23 33 For transmitters rated at a maximum output power not listed above the recommended separation distance f in metres m can be estimated using the equation applicable to the frequency of the transmitter where R is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer Note 1 At 800 MHz the separation distance for the high
28. de 2 2 4 POSTBRONCHODILATION TEST Same parameters as in FVC Comparing methods between PRE and POST Average between PRE and POST between REF and POST 511 900 MU2 e REV 2 02 Sibelmed Spirometer DATOSPIR 600 29 between PRE and POST Difference between PRE and POST Graphics Superposition PRE and POST in the external printer 2 2 5 BRONCHOCONSTRICTION TEST Parameters FVC 1 Forced Vital Capacity FEV1 1 Idem in 1 second PEF l s Peak Espiratory Flow FEF25 75 l s forced mid espiratory Flow AIl the FVC test parameters can be selected Data of Patient identification Environmental data of temperature pressure and relative hu midity Continuous or shorter methods Deviation Percentage between Basal and solution Superposition of graphics in FLOW VOLUME or VOLUME TIME Chronometer for controlling the steps Type of medicine and accumulated dose Calculation of PD20 FEV1 by mathematics adjustment or li near interpolation Numeric and graphic dose response data summary on screen Link with bronchodilatation test 2 2 6 CALIBRATION Calibration Program for dynamic tests with a syringe volume of 1 to 6 litres Record of the last calibrations Indication of calibration warning if wanted 2 2 7 PROGRAM SETUP The Software Setup can be performed by the user in the fo llowing aspects Type of printer Parameters diagnosis references and others
29. ding cables than the re commended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance 3 5 Radiated RF 3 V m 3 V m d Bele ee 80 MHz a 800 MHz d HF de 800 MHz a 2 5 GHz EN IEC 61000 4 3 from 80 MHz a 2 5 GHz where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recom mended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey a should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equip ment marked with the following symbol 2 Note 1 At 80 MHz and 800 MHz the higher frequency range applies Note 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people 4 Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the Datospir 600 is used exceeds the applicable RF compliance level a
30. echnical service Tel 34 93 433 54 50 email sat sibelmed com Fax 34 93 436 16 11 Web www sibelmed com Sibelmed Spirometer DATOSPIR 600 5 SAFETY SPECIAL PRECAUTIONS The spirometer DATOSPIR 600 has been designed to have the maximum safety All the operation instructions must be read before starting the DATOSPIR 600 Otherwise injures to the user or the patient and damage to the device and or accessories might occur INTENDED USE The spirometer measures and calculates a long list of human respiratory function parameters The spirometer is not designed to be used in open air conditions or under any other conditions or energy supply not foreseen in this manual The spirometer is not intended to be used in moving transport vehicles It is adviseble to use the device in an acoustic envi ronment enough silent to allow the patient make the manouvers correctly and hear the acoustic warnings The device must be located in a safety position This avoids it falls down and consequently any failure to the device or damage to patient and or user USER PROFILE The spirometer is designed to be used by medical staff only being supervised by a physician Specific training in spirometry is recommended Bronchoconstriction test must be performed and supervised by qualified staff User must be familiarized with the functioning of the device be fore beginning to perform tests with patients All necessary information can
31. ed to use flexible or disposable sensors 5 Consulte el ANEXO 1 del manual de uso del software W 20 de espirometr a para realizar las pruebas de PULSIOXIMETRIA con dicho programa 1 6 PROCEDURE FOR PERFORMING THE CALIBRA TION For the calibration procedure follow the SPIROMETRY SOFT WARE SIBELMED W 20 USER S MANUAL 1 14 PROCE DURE FOR PERFORMING THE CALIBRATION 1 7 UPDATING THE DEVICE SOFTWARE For the update the internal software follow the SPIROMETRY SOFTWARE SIBELMED W 20 USER S MANUAL 1 15 UP GRADING THE W 20 APPLICATION AND INTERNAL SOFT WARE FOR THE DATOSPIR 600 1 8 TECHNICAL SUPPORT If any problem doubt suggestion arises before during or after the use of the device it is recommended to follow these steps 1 Use the helps available in the program 2 Consult the Use Manual 3 Contact with the After Sales Service of SIBEL S SIBEL S A Rossell 500 08026 BARCELONA SPAIN AFTER SALES SERVICE Tel 34 93 433 54 50 FAX 34 93 436 16 11 e mail sat sibelmed es 511 900 MU2 e REV 2 02 SUOIPNAZSUI Instructions Sibelmed Spirometer DATOSPIR 600 2 TECHNICAL SPECIFICATIONS 2 1 SOFTWARE COMPATIBILITY Windows 95 98 Windows 2000 NT XP Windows 7 2 2 TYPES OF TESTS FUNCTIONS AND SPIROMETRIC PARAMETERS 2 2 1 FORCED VITAL CAPACITY FVC Parameters FVC 1 Forced Vital Capacity FEVS 1 Forced Espiratory Volume in 0 5 seconds FEV1 1 Idem in 1 second FE
32. er frequency range applies Note 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people 511 900 MU2 e REV 2 02 Sibelmed 7 Spirometer DATOSPIR 600 511 900 MU2 e REV 2 02 suonon nsur
33. h impedes the normal use disconnect the device from the power supply and contact the After Sales Service of SIBEL S A specifying as detailed as possible the type of anomaly detected 511 900 MU2 e REV 2 02 Sibelmed Spirometer DATOSPIR 600 6 MODIFICATIONS 511 900 MU2 61 e REV 2 02 suonon nsur Instructions Sibelmed Spirometer DATOSPIR 600 Guidance and manufacturer s electromagnetic immunity The Datospir 600 is intended for use in the electromagnetic environment specified below The customer or user should assure that it is used in such environment Immunity test EN IEC 60601 test level Compliance level Electromagnetic environment Guidance Electrostatic discharge ESD EN IEC 61000 4 2 6 kV contact 8 kV air 6 kV contact 8 kV air Floors should be wood concrete or cera mic tile If floors are covered with synthe tic material the relative humidity should be at least 30 96 Electrical fast transient burst EN IEC 61000 4 4 2 kV for power supply lines X1 kV for input output lines 2 kV for power supply lines Not applicable Mains power quality should be that of a typical commercial or hospital environ ment The input output connection cables do not surpass 3 metres length Surge EN IEC 61000 4 5 1 kV in differen tial mode 2 kV in common mode 1 kV in differen tial mode 2 kV in common mode Mains power qu
34. ibelmed Spirometer DATOSPIR 600 A a DISPOSAL OF WASTE ELECTRICAL ELECTRONIC AGREEMENT TO THE WEE DIRECTIVE Q DO NOT REUSE For devices with pulse oximetry module A APPLICABLE PART B SPO IPN N DEGREE OF PROTECTION AGAINST WATER 511 900 MU2 e REV 2 02 Sibelmed Spirometer DATOSPIR 600 39 3 FUNCTIONING PRINCIPLES The spirometer DATOSPIR 600 is a device of physiological signal acquisition and information processor which providesthe signal for the lung function In order to perform the processing it is necessary to change the physical into electrical magnitude The units which perform this change are the transducers The DATOSPIR 600 has three different transducers a Turbine b Neumotachometer Fleisch and c Disposable neumotachometer The turbine performs a transduction function in two steps the volume to measure passes through the turbine and prints a ro tor turn proportional to that volume This rotor turn is detected by the interruption of an infrared beam which sensor converts the entering light into an electrical digital signal The function of the transduction in the Fleisch and Disposable neumotachometers is also performed in two steps The air flow through the neumotachometer creates a difference of pressure which is converted into electric signal through a pressure trans ducer 3 1 TURBINE The turbine is axial with two startors in a spiral form and the ro tor consisting of a flat rectangular
35. ill be applied The series of spirometer DATOSPIR 600 consists of three diffe rent models depending on the options included DATOSPIR 600 F DATOSPIR 600 T DATOSPIR 600 D The enclosed table shows the basic characteristics for each mo del standard X and other optional parts or functions O A model can be transformed into a superior one by adding the corresponding parts In that case consult the Commercial De partment of Sibel S A or your distributor OPTIONS DATOSPIR 600 F T D Transducer FLEISCH eere X O O Transducer TURBINA enr O X O DESECHABLE Transducer O o X FVC VC and MVV tests in PRE and POSTbronchodilation mode x X X Bronchoconstriction Test X X X Graphics superposition X X X Auto check program nennen X X X Graphic incentive for children x x X Setup program eene nnne X X X Data Bases es e seen esse in X x x Printing with external printer X X X Transfer via INTERNET through PC of Patients Tests eere x x x Device CHECK UP esee X X X Software update eene x X x Calibration Program nnne X X X Export of tests to other systems X x x Module of electronic weather
36. nd status variables Central Process Unit CPU Communications controller 3 9 2 PROGRAM The program for control is developed in assembler language and C high level language ensuring a high speed in time control and structured programming It is divided into two parts the bios in EPROM and the aplication FLASH 511 900 MU2 e REV 2 02 SUOIPNAZSUI Instructions Sibelmed Spirometer DATOSPIR 600 44 3 9 3 MEMORY The storage capacity of temporal data and the capacity of the setup is 128 KB in RAM 3 9 4 CPU This device manages and executes the process which is codified in the instructions composing the program The microcontroller H8 532 of Hitachi is used as CPU 3 9 5 CONTROLLERS They perform the information transference between the CPU and the rest of devices like the keyboard the screen and the printer They are included in the printed circuit of the microcon troller except the interphase of the serial communication chan nel RS 232 and the screen controller 3 9 6 QUALITATIVE DESCRIPTION The control program performs the signal acquisition and its tem poral storage It also makes the communication management with the PC In this sense it translates and executes the com mand received from the PC The spirometry program allows that the spirometry signal treatment meets the applicable norms taking into account the calculations of Identification of the espiration start The start of the test is
37. nsfer is controlled by a microprocessor In the PC platform a powerful software is installed which controls analyses stores and dis plays the spirometric signals It works under Microsoft Windows It enables among other functions The management of different Data Bases The performance of FVC VC MVV and Postbronchodilation tests The graphic presentation in F V and V T modes The selection of different Reference Parameters The selection of different diagnosis types The printing of different reports The presentation of graphics for motivated tests with children The spirometer DATOSPIR 600 has been developed by the de partment of R D of SIBEL S A in collaboration with Labo ratory of Pulmonar Function in the Hospital de la Santa Creu i Sant Pau of Barcelona according to the Quality Manual of Sibel S A and in concordance with the quality standards EN 46001 and ISO 9001 as well as the European Medical De vice Directive 93 42 EEC According to this directive it is considered as a product of class IIa It also meets the norms of Electric Safety of the product EN60601 1 IEC 601 1 and the Electromagnetic Compatibility Standards EN 60601 1 2 View annex Electromagnetic Compa tibility 511 900 MU2 e REV 2 02 Sibelmed Spirometer DATOSPIR 600 11 1 2 PREVIEW This User s Manual is oriented to all the models and op tions which can form the spirometer DATOSPIR 600 For each case only the options or functions for each model w
38. o evaluate the toxicity of SpO2 sensor 511 900 MU2 e REV 2 02 Sibelmed Spirometer DATOSPIR 600 23 The maximum recommended application s time of an oximeter in the same place is 8 hours The point of placement must be reviewed frequently to determine the position the movement and the skin sensitivity of the patient The reaction to the sen sors by the patients may be different depending on their health and skin conditions No adhesive material should be used if the patient has an allergic reaction to it For log term monitoring is recommended to use flexible or dis posable sensors The adult sensor is intended for use on people over 12 years old The peadiatric probe is for children between 3 and 12 years Although the adults probes can be used on any pediatric patient whose fingertip reaches the finger stop of the sensor and on whom the sensor fits securely The system can measure pulse and functional oxygen satura tion A functional meter can not be used to evaluate the accura cy of pulse oximeter probe or a pulse oximeter monitor DEGREE OF PROTECTION AGAINST LIQUIDS Degree of protection against harmful ingress of water Drip proof IPX1 1 5 2 PULSEOXIMETRY TEST PROCEDURE WARNING Use only the oximetry sensor supplied by the DATOS PIR 110 120 spirometer manufacturer If you use non validated sensors with this equipment that may cause significant measurement errors 1 Plug the pulse oximetry sensor supplied
39. of a manoeuvre will be judged by its start course and end by observing the pa tient and the graphic layout The start must produce a sudden neat defection The course must draw a concavity curve going smoothly upwards without any rectification The end should be asintotic and not perpendicular or sudden Volume time The measurement of the espired volume during a forced manoeuvre is influenced by the selection of its starting point This requires to choose a criterion of manoeuvre start and maintain it consis tently The mentioned retrograde extrapolation is the most con sistent and accepted method by European and American labo 511 900 MU2 e REV 2 02 Sibelmed Spirometer DATOSPIR 600 47 ratories and the preferred method unless other methods prove similar results The volume extrapolated by this method should be lower than 5 of the vital capacity or than 150 ml without surpassing any of both criteria In order to achieve a good spirometry the technician must m make sure that the patient s effort is maximum that the start is correct and that no caugh or Valsalva manoeuvre due to glottis closing have been produced Pay special attention to avoid an excesively early ending of the espiration which would be de tected at the end of the curve showing the horizontal base line too perperdicular Sometimes the patient partially blocks the mouthpiece with his tounge or his false teeth As an essential criterion the two best es
40. on 3 7 of the general manual 3 8 2 CONTROL PROGRAM The control program performs the processing of the acquired signal Among the important calculations we must point out Start and end of the manoeuvre 511 900 MU2 e REV 2 02 Sibelmed Spirometer DATOSPIR 600 43 The start of a manoeuvre is considered when the level of 3 cmH20 is surpassed The end of the manoeuvre is considered when there is a pressure variation lower than 1 cmH20 for 2 s Delay for the calculation For the calculation of the maximal pressure to avoid artefacts a initial period of time is discarded This period is set to 1 sas a default but it can be set up between 0 1 anf 4 9 s Order of the manoeuvres The manoeuvres are saved in the memory in the same order as they have been performed Automatic deleting of a remaining manoeuvre When the 5 memories are full and a new manoeuvre is per formed the first manoeuvre is always deleted if this is not the best If the first is the best then the second one is deleted 3 9 MICROPROCESSOR 3 9 1 PHYSICAL DESCRIPTION The microprocessor system consists of a series of electronic de vices which store manage receive and send pieces of informa tion It is divided into Program of hardware basic control BIOS resident in EPROM of 32KBytes Spirometry program and device management Data base for tests resident on memory FLASH of 1MBytes Memory RAM of 128KBytes for storing the device setup a
41. on of the equipment The operations to be carried out are as follows 5 1 1 CLEANING OF THE NEUMOTACHOMETER OR TUR BINE TRANSDUCER A Neumotachometer Fleisch The neumotachometer is the most delicate part of the spirome ter so special care must be taken in its handling As the neumotachometer is the part directly exposed to the pa tient it is necessary to maintain it in perfect physical and hygie nical conditions To this purpose proceed as follows 1 The rubber mouthpieces can be disassembled and the lineari zer cones can be taken out as in the drawing 5 1 511 900 MU2 e REV 2 02 Sibelmed Spirometer DATOSPIR 600 55 LINEARIZED CONE S LAMINATOR _ RUBBER MOUTH PIECES e PNEUMOTACHOMETI BODY Fig 5 1 2 The laminator can be taken out turning to the left and pulling as in the drawing 5 1 3 The mouthpieces cones and laminator can be washed with soap and water The procedure must be very careful due to the structure of the laminator 4 Once cleaned it is convenient to clean it again with distilled water in order to avoid the salt sediments specially in the flow laminator 5 The final dry can be made with a simple electri cal dryer e g a hair dryer to accelerate the process Take care that the laminator does not reach a temperature over 130 C so do not bring the dryer near the laminator for more than 15 or 20 cm and do not maintain it for a long time 6 The laminator housing and the ne
42. or 50 ml3 or 50 ml3 or 50 ml Flow the highest 5 or 200 ml5 or 200 ml5 or 200 ml Temporal accuracy 0 5 0 5 0 5 Resolution in volume ml lt 1 lt 6 lt 3 Sampling rate Hz 100 25 100 511 900 MU2 e REV 2 02 Sibelmed Spirometer DATOSPIR 600 31 Accumulative Volume Time Three curves FVC of maximum 60 seconds each Three curves VC of maximum 60 seconds each Three curves MVV of maximum 60 seconds each 2 4 ANALYSIS CRITERIA Start espiration FVC By the retrograde extrapolation method Final espiration FVC When the accumulated volume in the last second is lower than 0 03 litres Selection of tests FVC According to the criteria of maximum addition of FVC FEV1 or at the operator convenience Selection of parameters FVC and FEV1 of the highest value among the stored tests For the rest of parameters in the selected test the one with the highest addition is recommended Start of espiration in VC and MVV by signal level Selection of tests and parameters in VC and MVV Highest value in VC or MVV 2 5 ELECTRONIC WEATHER STATION Temperature from 0 to 50 C 1 C Pressure from 375 to 780 mmHg 5mmHg Humidity from 0 to 100 5 2 6 MAXIMAL PRESSURES MODULE 2 6 1 PARAMETERS In both espiratory and inspiratory test the next values are mea sured Maximal pressure of the 5 manoeuvres Average of the best 3 Standard deviation of the best 3 511 900 MU2 e REV 2 02 SUOIPN
43. piece The form of the startor makes the air flow passing through the turbine to acquire a turn responsible for the rotor turn The functioning of the turbine is based on the theory of Flow Mechanics specially in the Turbo machines In this particular case the angle turning the rotor is directly proportional to the flow volume passing through the turbine and the proportionality constant depends on the turbine physical form 3 2 TURBINE TURN DETECTOR The turbine turn detector consists of three couples of emitter diode and fotodetector of infrared light invisible which conve niently diposed allow to detect the rotor turn and its direction The number of beam interruptions is the same as an accumula ted angle of rotor turn that is the air volume passing through 511 900 MU2 e REV 2 02 SUOIPNAZSUI S L Instruction Sibelmed Spirometer DATOSPIR 600 40 the turbine The photodetector provides an electrical digital sig nal which is the same as the light beam interruptions This is directly acquired by the microprocessor 3 3 NEUMOTACHOMETER FLEISCH The neumotachometer Fleisch is based on measuring the pres sure drop obtained between the ends of an obstruction which allows the air pass in a quasi capillar mode By applying the Poiseuille law the relation between the flow and the pressure is linear PRESSURE ct x FLOW In the neumotachometer Fleisch the obstruction is formed by multiple capillar tubes Each tube p
44. pirations out of the three best accepta ble curves cannot differ more than 200 ml in the FVC or in the FEV1 The best effort cannot be determined only by simple inspec tion of the spirometric curve Measurements must be checked in order to determine the maximum values The independent selection of FVC and FEV1 sometimes causes a slight increase of variability since factors such as learning fatigue or bronchos pasm induced by the espiration play a part It is not necessary to discard the best FEV1 when the manoeuvre where it comes from has finished prematurely On the contrary the FEF25 75 is influenced by the vital capacity of the selected curve Mis taken high values may result if we have selected a manoeuvre with reduced vital capacity and inferior to the individual s actual one Apparently the most practical way to carry out its calcu lation is by choosing the manoeuvre with the maximum Vital Capacity and the FEV1 whose addition is the maximum among the three selected ones 4 2 CALIBRATIONS Besides the calibration procedures incorporated to the unit by the manufacturer for a quick checking of the running of circuits and basic machinery of the pneumotachometer the unit should admit check out by means of applying external signals These signals must bear the maximum similarity to the biological sign for which the instruments have been designed i e forced es piration as well as to the flow magnitude volumes and times 51
45. resents a resistance to the air pass which produces a pressure drop in its ends The reason for the existence of so many tubes and its small dia meter is that the air can pass through the obstruction in laminar regime The relation flow pressure is linear to enable the largest range of flow avoiding the turbulence effects The flows produced in the forced spirometric tests are clearly turbulent It is convenient that the flows became laminar in or der to obtain a correct measurement in the resistive area This can be achieved by reducing the maximum the tube diameter On the contrary the norms require that this resistance to the air pass is under a limit so that the tests measurements are not affected The best solution implies many little tubes so that the air flow is laminar when it passes through each tube The presence of so many resistors in parallel makes the total value low enough So as not to affect the measurement In fact the response of the neumotachometer Fleisch is linear in the low flows deriving gradually towards a squared behaviour in high flows where the regime is transformed into a turbulent one This error is about 2 in flows from O to 12 l s Never theless two flow linearizers have been included which reduce the mentioned error These devices consist of two metalic mesh cones located in each air flow inlet Furthermore the software 511 900 MU2 e REV 2 02 Sibelmed Spirometer DATOSPIR 600 41 incl
46. s directed to keep the device in a good condition of use Four types of preventive maintenance are established 1 The device by starting performs a comprobation of some of its parts 2 A second type which can be carried out by the same user consists of a periodical supervision of the aspect of the different 511 900 MU2 e REV 2 02 Sibelmed Spirometer DATOSPIR 600 59 interconnections and other external elements of the device In this supervision you will verify that all the interconnections are perfectly connected that all the cables and or connectors as well as other elements do not present breakages or external damages If any anomaly is detected which the user cannot resolve by himself inform the aftersales service of SIBEL S A or your Distributor so that the y proceed to check or repair it 3 The user can enter the Maintenance Program to adust and or verify some parts of the device as detailed in paragraph 1 15 4 The fourth type consists of a general technical verification of the safety systems adjustments functions etc which configu rate the device THIS TECHNICAL VERIFICATION WILL BE PERFORMED WITH ANNUALPERIODICITY and according to the Verifica tion and Adjustment Procedure of the DATOSPIR 600 available by the manufacturer This type of operations must be performed by qualified technical personnel of the maintenance department of the centre technical service of your distributor or the manu facturer
47. t Requirements e EN ISO 14971 2012 Risk management in medica equipment WASTE e RD 208 2005 Electrical and electronic equipment and waste management Transposition of WAEE 2002 96 CE Directive 3 A 3 To be satisfied by the user DATA PROTECTION Applicable to the W20 Software accompanying the DA TOSPIR 600 see specific user s manual e Compliance with LOPD and 95 46 CE Directive WASTE e RD 208 2005 Electrical and electronic equipment and waste 511 900 MU2 e REV 2 02 suononajsum Instructions Sibelmed Spirometer DATOSPIR 600 management Transposition of WAEE 2002 96 CE Directive Relative Humidity Lower than 75 without condensation Pressure Between 525 and 800 mmHg 3000 to 400 metres high ap proximately Temperature Storage temperature between 5 and 709C Working temperature between 10 and 409C Power supply Mains 220 V 10 50 60 Hz other optional Power Inferior to 25 VA Dimensions 195 x 165 x60 mm Weight 1 Kg approximately without accessories Useful life 7 years 511 900 MU2 e REV 2 02 Sibelmed Spirometer DATOSPIR 600 37 2 9 SIMBOLOGY O H Phy Boos E SERIAL NUMBER MANUFACTURER The date of manufacture name and address of manufacturer LIMITATION TEMPERATURE HUMIDITY TEMPERATURE PRESSURE TEMPERATURE DIRECTIONS FOR USE LOT EXPIRY DATE CAUTION LAND 511 900 MU2 e REV 2 02 SUOIPNAZSUI Instructions S
48. terr nea P Morales J Sanch s P J Cordero y J L D ez ARCHIVOS DE BRONCONEUMOLOGIA Vol 33 num 5 1997 B SH WILSON Predicted normal values for maximal respiratory pressures in caucasian adults and children SH Wilson NT Cooke RHT Edwards SG Spiro THORAX 1984 39 535 538 C BLACK amp HYATT Maximal Respiratory Pressures Normal values and relationship to age and sex Black LF Hyatt RE AM REV RESPIR DIS 99 696 702 1969 D MR CHARFI Les pressions ventilatoires maximales la bouche chez l adulte valeurs normales et variables explicatives MR Charfi R Matran J Regnard MO Richard J Champeau J Dall ava A Lockhart REV MAL RESP 1991 8 367 374 511 900 MU2 e REV 2 02 SUOIPNIAZSUI Instructions Sibelmed Spirometer DATOSPIR 600 54 5 PRESERVATION PREVENTIVE AND CO RRECTIVE MAINTENANCE The DATOSPIR 600 requires first of all as any device and spe cially for medical applications a preservation or maintenance directed to the safety of the patient operator and environment and secondly to ensure the reliability and accuracy of the functions for which it has been developed All of this means a series of routines which must be carried out 5 1 PRESERVATION Preservation is the action directed to maintain the device in a correct operation condition and the person in charge of it does not require any special technical quality except for the proper knowledge of the functions and manipulati
49. the indications are fulfilled the device is ready to be setup B INSTALLATION OF SPIROMETRY SOFTWARE For the Software installation in the PC hard disk follow the SPI ROMETRY SOFTWARE SIBELMED W 20 USER S MANUAL 511 900 MU2 e REV 2 02 suonsn 13SuT Instructions Sibelmed Spirometer DATOSPIR 600 22 1 5 1 PULSIOXIMETRY 1 5 1 SAFETY INTENDED USE This oximetry sensor should be used by a physician or under the supervision of medical staff The pulse oximeter does NOT require calibration The pulse oximeter has NO physiological alarms Pulse oximeter probes do NOT allow temporary immersion The pulse oximeter waveform is NOT normalizzed Patient movements or excessive lighting can affect the accuracy of the device The pulse oximetry module has CE marking and can not reach temperatures 42 0 The oxygen saturation and heart rate measures must be per formed using the sensors manufactured by MEDIAID POX 050 1055 clip and POX050 820s Flexible which have been validated clinically Otherwise there may be significant measu rement errors These pulse oximetry probes have been validated for the M15 module from MEDIAID The wavelengths used are 660 nm red and 910 nm infrared and the optical power is about 9 6mW Consult the instructions for use of the probes before use Fo llow strictly manufacturer s safety instructions as well as those specified in this manual See instructions for use of the sensor t
50. the system from O to 15Hz 511 900 MU2 e REV 2 02 suonona4jsug Instructions Sibelmed Spirometer DATOSPIR 600 42 3 7 ANALOGUE DIGITAL CONVERTER The analogue digital converter samples the analogue signal when the processor indicates it and quantifies the analogue signal of its input in the case of the pressure transducer As a result it gives a digital word at the output which expresses a numeric value The converter used in the DATOSPIR 600 has 12 bits and then 4096 levels are available for assigning to the pressure signal The 2048 superior levels are used for the espi ratory flows and the 2048 inferior ones for the inspiratory levels Both the resolution and the dynamic range converter used cover widely the specifications and recommendations of the interna tional organisms 3 8 MAXIMAL PRESSURES MODULE The DATOSPIR 600 optionally has an external Module of Maxi mal Respiratory Pressures This module is connected to the DA TOSPIR through a phone connector 3 8 1 SIGNAL ACQUISITION The module of maximal pressures includes basically a pressure sensor a differential amplifier and a filter The pressure sensor covers the range from O to 300 cmH20 The output of this sensor is amplified and filtered so that the analogical signal has the intended range and bandwidth Then this signal is transformed into digital with a A D converter The converter used is the same as the one used in the spirome try See secti
51. uce an increase of the emissions or a decrease in the device immunity REMOVAL OF WASTE FROM ELECTRICAL AND ELEC TRONIC APPLIANCES BY DOMESTIC USERS IN THE EUROPEAN UNION A mmm This symbol on the product indicates that you cannot dis pose of the product with domestic waste 511 900 MU2 e REV 2 02 Sibelmed Spirometer DATOSPIR 600 9 However any removal of this type of waste is the responsibi lity of the user and must be taken to a designated collection point for the recycling of electrical and electronic appliances The separate recycling and collection of this waste at the time of removal will help preserve natural resources and ensure that recycling protects your health and the environment Should you require further information on the places where you can leave this waste for recycling contact the local authorities in your town or city the domestic waste management service or the distributor who sold you the product 511 900 MU2 e REV 2 02 A19jes Instructions Sibelmed Spirometer DATOSPIR 600 1 INSTRUCTIONS FOR USE AND INSTALLATION 1 1 INTRODUCTION The spirometer DATOSPIR 600 is a compact device held in a platform type C It has different types of transducers Fleisch turbine and or disposable It can include a module for mea suring the Inspiratory and Espiratory Maximal Pressures MIP MEP or PIM PEM and other module for Pulseoximetry measu rements SpO2 The system of data acquisition and tra
52. udes a compensation of linearization which improves the measurement In order to prevent the condensation and maintain these lineari ty characteristics the neumotachometer heats at a temperature of about 379C 3 4 DISPOSABLE NEUMOTACHOMETER The disposable neumotachometer has an obstruction or resistor to the air flow In this case the regime of air inside the neumo tachometer is turbulent for which the relation between flow and pression is squared and not linear Pressure ct 1 x FLOW 2 CT 2 X FLOW Nevertheless its simplicity allows the neumotachometer to be built more economically or even disposable 3 5 DIFFERENTIAL MANOMETER The Fleisch and disposable neumotachometers transform the air flow into a pressure drop between their ends The next step is to transform the pressure drop into an electric signal and for that we use a diferential manometer The pressure tranducer included in the Fleisch and disposable neumotachometers DATOSPIR 600 are of the semiconductor type with internal compensation in temperature 3 6 FILTERS AND AMPLIFIERS The analogue signal emitted by the pressure transducer inclu ded in the neumotachometers must be conditioned before being digitalized and processed This conditioning consists of a am plifying stage which adapts the dynamic range of the pressure transducer to the digitalizer range and a filter stage which re moves the parasite signals This filter limits the measurement band of
53. umotachometer exterior can be wiped with a dry cloth or wet with water drying afterwards the rest of humidity and taking care that no water can enter in the holes of the pressure inlet or in the transducer interior See drawing 5 2 Do not use abrasive substances or solvents 511 900 MU2 e REV 2 02 suonon vsuT Instructions Sibelmed Spirometer DATOSPIR 600 PRESSURE INLETS Fig 5 2 7 Assemble the set again according to drawing S Fig 5 3 If a microbian contamination is suspected it is necessary to use antiseptics in solution or more complex sterilizing procedures PRECAUTION DO NOT EXPOSE THE TURBINE TO TEMPERATURES EX CEEDING 70 C B Transducer type turbine As the turbine is the part directly exposed to the patient it is necessary to maintain it in perfect physical and hygienical con ditions To this purpose proceed as follows 511 900 MU2 e REV 2 02 Sibelmed Spirometer DATOSPIR 600 57 Fig 5 4 1 The turbine can be disassembled from the device housing by pressing smoothly to take it off 2 The turbine can be cleaned with soap and water Do not use solvents or alcohol etc that can damage the components Sin ce the reliability of the turbine depends on it take care so as not to damage it 3 Once it is cleaned with clear water it is convenient to avoid the salt sediment by clening it again with distilled water 4 The final dry can be made
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