MIR Spirolab 2 - Frank`s Hospital Workshop
Contents
1. In the can of an FVC tert after making at least twa valid tests the reproducibility of the parameters FVC FEVI and PEF i4 shown VC IVC and breathing pattern It is possible optional to begin the test by making several breaths at rest After three or four similar breaths a message VC IVC will indicate that the breathing pattern has been measured and that you can go ahead and make the VC or IVC test How to make a VC test When the message VC IVC appears inspire slowly as much air as possible into the lungs and then expire slowly as much air as possible How to make an IVC test When the message VC IVC appears expire slowly as much air as possibile and then inspire slowly as much air as possible To end the test press se or wait for 3 sec after last volume variation If you make the test without the breathing pattern respiratory function at rest then the measured parameters will be only VC or IVC MVV 29 46 Start the test making a series of forced inspirations and expirations breathing as deeply as possible The ideal frequency to instruct the subject is 30 breaths minute The test stops automatically after 12 seconds To finish press ee or wait 3 sec after the last volume variation At the end of the test the display shows shows the curves made and on the right of the display the measured parameter After viewing the curves press the key to view the related parameters the predicted values and the percentage2. To purchase appropiate mouthpieces generally either paper on plastic but in any cau mono sel disposable we uset Hat you contact your local distributor whe supplied the spirometer The user ia responsible to obtain the correct type of mouthpicces for the device There required are a dandard type with an outside In order ta avoid ambiental contamination caused by the disposal of the uted movthpieces the user must follow all relevant local neuletions 10 46 PROBLEMS AND UNFORESEEN ERRORS In case of any problems one of a uru of menage to indicate the nature of the problem will appear on Ue LOD display l appropriate and timely action is not taken in the went of such minaga appearing during the Life of the device then t in possible that the device will love its working memory SRAM lack of adequate car of the dwice e optration by non qualified on non trained porromndl lacking the nquind ability and or experience ur me ust of the device outside the guidelines described in this User s Manual uu of the device wen when rome operational anomali is encountered nonauthoriztd uwicing of the device improper incorrect and or umraronalle uu of the product Following the European Dinectine 93 42 CEE for MEDICAL DEVICES In the event of any accident caused by the device the user must inform the manufactur as quickly as posible 11 46 LABELS AND SYMBOLS Identification label of the spirometer model Spirolab R
3. FEV1 FEV1 and FVC with the respective normal predicted values It also calculates a series of indices as follows index measured values normal value x 100 The interpretation of these indices following the ATS standards then generates a series of messages corresponding to possibile levels of obstruction or restriction and one level of normal spirometry as shown in the following table normal spirometry very mild restriction or obstruction mild restriction or obstruction moderate restriction or obstruction severe restriction or obstruction very severe restriction or obstruction If it is not possibile to make the calculations for lack of data the interpretation is not valid and this message appears Not Valid Attention The interpretation during a tet wnion for ach whject nfen alway to the best tert uult 35 46 CONFIGURATION MENU CONFI GURATI ON MENU Delete data in memory Print last calibration Turbine calibration Printout header text Change DATE TI ME Choose operating language Choose predicted values Setup parameters Setup printout e DATE format dd mm yy e UNITS format cm Kg e Auto power off 60 min TO CHANGE DATE AND UNITS FORMAT SELECT AND PRESS ENTER CHOOSE ANY FUNCTION The various items within the configuration menu can be selected by pressing the corresponding number on the keyboard Delete data in memory WARNING ALL SPIROMETRY TESTS IN MEMORY WILL B
4. MAINTENANCE CLEANING AND STERILIZATION Cleaning the device The cleaning of the device must be made with a damp cloth Make sure to dry it afterwards Do not wet or immerse the device and power supply in any liquids Do not use any abrasive materials to clean the device Cleaning and sterilizing the turbine and the mouthpiece holder The maintenance operations to perform are the periodic cleaning and controlling of the turbine flow sensor The turbine guarantees the precision of the spirometry measurements and has the great advantage of requiring no periodic calibration In order to maintain this precision a simple periodic cleaning is required This operation also guarantees hygiene and thus safety for the subject lt is a good practise to control visually and to ensure that there are no foreign bodies hairs or similar objects deposited within the body of the turbine If this does happen then this can slow or even stop the free rotation of the turbine blade and thus compromise the accuracy of the measurements TTT optoelectronic turbine mouthpiece mouthpiece sensor holder Extract the mouthpiece and throw it away Extract the mouthpiece holder from the body of the optoelectronic sensor simply by pulling it from the mouthpiece holder If required it can also be pushed from behind Separate the turbine from the mouthpiece holder and immerge both in a cold sterilizing solution De not sterilize in an autoclave Tia operation woul
5. Mei tt faita Wg ga g fob F ma cananan n ALH 75 bgp meim i a EE ETETE A E EEE ria a s hey edge fo Peers PORT EPE PRE Eee Peel a 1 See CE an RE Mi r E a aa TE MF CU Pe a PTA aA i ee are ae ee a Cen a es a me ft a es ieee i mis sa Mss a TE aj gt ir FEV ont epee uy EH On Line operation of Spirolab Il with Winspiro software Install Winspiro to the PC and in General Configuration ensure that required COM port is selected the default is COM1 Connect the supplied RS232 cable both to the PC and to the Spirolab Il switch on the Spirolab Il From within the Winspiro software make a new subject card OR select an existing subject in either case make a new visit card with today s date Make the spirometry testing from within Winspiro The Spirolab II shows ON LINE MODE Connected via RS232 on the screen and the testing is made on the PC The results are calculated shown and stored within Winspiro Switch off the Spirolab Il when testing is finished WN mir MEDICAL INTERNATIONAL RESEARCH 44146 PROBLEMS CAUSES AND SOLUTIONS The device does not switch on Press firmly on the on key The internal battery may be discharged Make sure that the power supply cable of the charging unit is connected to the spirometer and that the plug is inserted correctly into the mains outlet then proceed with charging The LCD does not display Using the two app
6. Spirolab makes FVC VC IVC MVV and breathing pattern tests and calculates an index of test acceptability test quality control and a measure of reproducibility and also gives functional interpretation with 11 possibile levels following the latest ATS American Thoracic Society classification The main spirometric parameters are measured and displayed and all data with Flow Volume and Volume time curves can be printed out in seconds by the built in thermal printer The Flow Volume curve is shown in real time Each test can be repeated several times The best parameters are always available for rapid reference or printing Several sets of predicted or reference values can be selected from five different authors For example in general within the European Union the values recommended by the ERS European Respiratory Society are used The device also calculates the response to drug administration that is the percentage change between spirometry results obtained after the subject takes a drug and those prior to the drug PRE POST plus the results of a bronchial challenge test or a bronchodilation test A comparison of data is made between POST after drug and PRE before drug administration The keyboard is organized to be quick and user friendly thanks to the 15 programmed keys The internal memory can contain more than 1000 spirometry tests complete with Flow Volume and Volume time curves Spirolab is supplied with an RS 232 optoisol
7. observe the safety regulations of EN 60601 1 1 12 46 TECHNICAL FEATURES OF THE DEVICE Parameters measured ERV FEF25 ss Maximumflowat25 of FVC Ls FEF50 Maximum flow at 50 of FVC L s Average flow from 25 to 75 of FVC L s FEF 25 75 FET OO FEV FEVI FEV6 FEV FEV6 FEVI VC FEVI FEV6 FIVC FIVI RRO FVC FET FEV1 FEV1 FEV6 FEV1 o FEV6 FEV1 VC FEV1 FEV6 FIVC FIV1 Atti m Forced Vital Capacity FVC MVV min PEF s Is VE Ventilation at rest L min mL NINN i 13 46 Technical Specifications Temperature sensor Semiconductor 0 45 C Memory capacity Mod Spirolab around 400 tests Mod Spirolab Il around 1500 tests A complete test is comprised of the parameters the Flow Volume and Volume time curves The number of tests is approximate as it depends upon the configuration of the device and the type of tests made Display Mod Spirolab Graphic B W passive type FSTN LCD 320x240 pixel Mod Spirolab Il Graphic 16 colour passive type FSTN LCD 320x240 pixel Keyboard Silicon rubber keyboard 07 Hardware function keys with symbols 15 Software function keys with symbols 05 Easy search keys with symbols right left up down enter 02 Gender identification with appropiate symbols 10 Number keys 29 International alphabet keys Communication port interface RS232 bidirectional and optoisolated to 4KV Power supply Rechargea
8. predicted values To select one of the predicted value sets available for the calculation of normal values Setup parameters To enable or disable the printout of spirometry parameters Setup printout To enable or disable the printout of the F V and V t curves plus test interpretation DATE format dd mm yy To change the date format from da mm yy to mm dd yy Press enter to invert the selection UNITS format cm kg To change the units format from cm kg to in Ib Press enter to invert the selection Auto power off 6 min 1 to invert the selection To change the wait time for auto power off either 6 or 60 minutes Press enter 38 46 39 46 MEM FIND AND READ TESTS IN MEMORY Press this key to see the menu to view and to print all test data stored in the memory of the device FIND AND READ TESTS IN MEMORY Subject List Memory List CHOOSE ANY FUNCTION Subject List SUB ECT LIST INSERT LAST NAME OR THE FIRST LETTERS S OF LAST NAME TO FIND ALL MATCHINGS FILES IN MEMORY LAST NAME Insert the last name of the subject or just the first letter or letters of the last name All corresponding surnames found in memory will then be listed together with the FILE number Insert the relevant FILE number to view and or to print the corresponding spirometry report Press to print out the corresponding test s Memory list A list is shown of all the subjects tests held in memory of the device I
9. whether that minum is improptr incontct and or unreasonable or when the dwice is connected to an dichicel outlet which dots not conform ta the safely regulations im force The device and its nceerrorin must be contrelled before ach and wiry uu 10 that any malfunction and or damage caused during tranport and or storage may be detected Do not use the device in the presence of inflammable anacithetic sars oxygen or nitrogen Keep the device away from hot and or cold romeus The thermal paper used for printing is highly inflammable Keep away from open flames High frequency emissions that are outside the Limite expressed by the EN60604 1 2 may interfere with the cornet functioning of the device High frequency eminions coming from othr clichical or elichonic dicen can im fact intufere with the functioning of the device For this mason certian minimum clearances a few meter should be obuwed when bighnquancy appliances uch as W radio cellular phones de and other dectrowic units wnt operated in the samt room When connecting the Spirolab to any other devices PC printer modem etc the user mutt guarantee thet the nquind curity luivel for subjects and or usen in the same room aue not in any way indangered by the connection In order to maintain the rentiol safety characteristics laid down by EN 60604 1 1 only equipment which complies with the eurent safety regulations must be uud In cart the device in not functioning properly witch it of
10. E DELETED TO PROCEED INSERT PASSWORD ESC to Quit This option is used to delete all the test data in memory to quit without deleting the test data The password is 122333 The display then shows Test data have been DELETED Now available Memory is 100 HIT ANY KEY If the password is entered incorrectly the display shows 36 46 PASSWORD I NCORRECT ENTER to Retry ESC to Quit 5 to repeat the procedure Print last calibration To print the turbine calibration coefficient currently in use plus the date of the last calibration made Turbine calibration To modify the calibration of the turbine based on the FVC values for the expiratory phase and FIVC for the inspiratory phase measured during a test made with a calibration syringe SYRI NGE VOLUME cL 300 If FVC and FI VC O then use factory calibration ERR TOTAL ERROR BTPS Measure condition ATP Conversion from BTPS HIT ANY KEY ATP stands for Ambient Temperature and Pressure which indicates that the measurement conditions ant ambient lemptrature and preme BIPS stands for Body Temperature and Pressure Saturated which repent a wold tardord nference and pusm salrated In Line with the publication STANDARDIZED LUNG FUNCTION TESTING of the European Respiratory Society Vol 6 Supplement 16 March 1993 the ain expired from the mouth is at a temperatur of approximately 33 34 C The expired flow and volume ta be converted t
11. EF Spirolab 3 S N A23 051xxx ON mir MEDICAL INTERNATIONAL RESEARCH Via del Maggiolino 125 00155 Roma Italy mir spirometry com IN CE 0476 REF Spirolab Il S N A23 050xxx MEDICAL INTERNATIONAL RESEARCH Via del Maggiolino 125 00155 Roma Italy 4 mir spirometry com R C 0476 The identification label on the underside of the housing shows the product name plus the following e Manufacturer s name and address e Product conformity marking in line with the CE 93 42 guidelines e Serial number of the device 0476 EC mark for medical devices The product is certified to conform to the requirements of the 93 42 CEE medical devices directive its component parts are of type BF and therefore protected against the Electrical safety symbol In accordance with the EN 60601 1 the product and danaers of direct and indirect contact with electricity Other symbols on the device Warning symbol for the connection of the power is supply DC IN 12 V To charge the internal battery use only and exclusively the original power supply 12 V 1A DC guaranteed and certified to the EN 60601 1 Safety Standard TURBINE Warning symbol for the turbine connector Use only and exclusively the original turbine flow sensor DC OUT 5 A S Warning symbol for the RS232 serial port For connection to other RS 232 devices such as PC or printer RS 232 port use only the serial cable supplied by the manufacturer and
12. ERATING THE SPIROMETER Charging the battery Switching on the spirometer Backlight settings Contrast settings Loading the thermal paper Connecting the flow sensor Switching off the spirometer SPIROMETRY FUNCTIONS INSERT MODIFY NEW SUBJECT DATA Modify subject data Automatic insertion of a subject FILE 4 46 Pg 22 Pg Pg Pg Pg Pg Pg Pg Pg Pg Pg Pg Pg Pg Pg Pg Pg Pg Pg Pg Pg Pg Pg Pg Pg Pg Pg Pg Pg Pg Pg Pg Pg OOOO 10 10 10 11 12 12 13 13 14 16 17 18 19 21 21 21 21 21 21 23 24 26 27 27 Pg SPIROMETRY FVC VC IVC MVV How to make spirometry testing FVC VC IVC and breathing pattern MVV SPIROMETRY POST DRUG TESTING 1st case current subject 2nd case subject from FILE Physiological test placebo VIEWING AND PRINTING THE RESULTS TEST QUALITY CONTROL OF THE SPIROMETRY REPRODUCIBILITY OF THE FVC TEST METHOD OF MEASUREMENT AND INTERPRETATION CONFIGURATION MENU Delete data in memory Print last calibration Turbine calibration Printout header text DATE format dd mm yy UNITS format cm Kg Change DATE TIME Choose operating language Setup parameters Setup printout FIND AND READ TESTS IN MEMORY Subject List Memory List FILE ORGANIZATION MAINTENANCE CLEANING AND STERILIZATION Cleaning the device Cleaning and sterilizing the turbine and mouthpiece holder Verify the free moveme
13. Spirolab Spirolab I User s Manual User s Manual Rev 2 Prepared by Massimiliano Perillo Yn Llo Date 09 07 2001 Approved by Paolo Sacco Boschetti Poclal Date 09 07 2001 7 5 A 1 46 Thank you for choosing a product from MIR Medical International Research The original packaging contains one of the following spirometers with its respective accessories Article Description code P 910560 Spirolab with Black White LCD display 220V power supply 910561 Spirolab with Black White LCD display 110V power supply 910550 Spirolab Il with colour LCD display 220V power supply 910551 Spirolab Il with colour LCD display 110V power supply 672685 Nylon carrying case 910320 Nose clip 910350 Roll of thermal paper 910300 Sample of disposable paper mouthpiece 671492 Connection cable RS 232 9 pin for PC 910110 Serial parallel printer converter optional 980060 Users manual in English 270464 Spare fuse internal 2A 270468 Spare fuse internal 4A Before using your spirometer e Please read this manual carefully plus the labels and all of the information supplied together with the product e Set up the device date time language predicted values etc under Configuration Menu in this Manual Keep the original packaging e Inthe event that your spirometer has a problem then you must use the original pa
14. are then modified by a percentage which is according to ERS and published in THE EUROPEAN RESPIRATORY JOURNAL Volume 6 Supplement 16 March 1993 Standardized Lung Function Testing paragraph 5 3 By entering the number 0 zera no thie correction will be made to the calevlation of the predicttd valuu It ia poll ta enter nic group n 10 ta define a custom coruction percentage of predicted values thet goer from SO ta 200 of the predicted value nm Wt Modify subject data To modify subject data press the key and repeat the data entry procedure All data not to be modified must be confirmed by pressing k Automatic insertion of a subject FILE 27 46 Press the key Enter the existing subject ID code and press In case the ID code of a subject s FILE cannot be remembered then it is possibile to find it by using MEM function 28 46 SPIROMETRY FVC VC IVC MVV All the subject s data must be inserted before making a spirometry test The test can be made from the main display or from any display that show a previous test result last test best test or test in memory Selection of the spirometry test Fvce To make the FVC test ve To make the VC IVC test and breathing pattern tests if required To make the MVV test As the test is carrying out the Flow Volume curve or the Volume time curve are shown on the display in real time The test must begin within 30 seconds after pressing the start key otherwise
15. ated serial communication port which guarantees excellent electrical protection gt 4 KV both for the doctor and for the subject and respects the most severe European safety requirements EN 60601 1 The machine can be connected directly to the serial port of a printer using the standard RS 232 communication port To connect to the parallel port an optional serial to parallel converter is required The internal software or firmware inside the device can be upgraded quickly and simply from a PC To make this upgrade consult the manufacturer or an authorized representative 16 46 ILLUSTRATION of Spirolab 1 Flow sensor 2 Thermal paper container lid 3 Flow sensor compartment 4 Black and White Display 5 Keyboard 17 46 ILLUSTRATION of Spirolab Il 1 2 3 4 5 1 Flow sensor 2 Thermal paper container lid 3 Flow sensor compartment 4 Colour display 5 Keyboard 18 46 KEYBOARD ILLUSTRATION MENU Mod Spirolab Spirolab Il Green LED Orange LED Green LED Device on Battery charging Battery charged switch on Switch Off A Number keys Correction key to cancel the number inserted press twice to return to the number inserted previously when used for viewing pages shows the previous page B ENTER key and scroll forward key when viewing pages Adjust contrast Press several times as required Adjust brightness Press several times as required Advance the printer paper Self check k
16. be printed by pressing Ka from the main screen at the end of a test and when viewing best last test To print a test result in memory after recalling it press the Rie To interrupt printing press Se The printout consists of a heading with date time and the BTPS factor at the moment of the test subject data the FILE number the ethnic correction percentage chosen if any and the author of the predicted values Then follow the Flow Volume and Volume time curves which can be from the last test or the best test By pressing from the main screen the best test will be printed To print instead the last test press when viewing the data related to the last test A list of the measured parameters plus the test interpretation then follow In case of a PRE test the following values are shown Pred predicted values PRE values measured before the administration of drugs Pred percentage values compared to predicted values In case of a POST test the two curves will be superimposed and in addition to the parameters previously described the following are shown POST measured value after the administration of drugs CHG represents percentage variation between POST and PRE 32 46 TEST QUALITY CONTROL By applying a series of mathematical calculations quality control to certain key parameters Spirolab produces a series of test comments which are useful to understand how well the test was performed Vext and PEFT ERROR If the ex
17. ble battery Ni MH 6 elements 1 2V each 4000 mAh Dimensions 310x200x65mm Weight 1 9 kg Flow volume measurement system Bidirectional digital turbine Measurement principle Infrared interruption Volume range 10 L BTPS Flow range 16 L s BTPS Volume accuracy 3 or 50 mL Flow accuracy 5 or 200 mL s Dynamic resistance at 12 L s lt 0 5 cmHoO L s Type of electrical protection Class II device Safety level for shock hazard Apparatus type BF Protection against water penetration Standard device Safety levels during use in presence of inflammable anaesthetic gases or oxygen or nitrogen Apparatus not suitable Conditions of use Apparatus for continuous use Conditions of storage Temperature MIN 0 C MAX 40 C Humidity MIN 10 RH MAX 95 RH 14 46 Operating Conditions Temperature MIN 10 C MAX 40 C Humidity MIN 10 RH MAX 95 RH Applied norms Electrical Safety Standard EN 60601 1 Electro Magnetic Compability EN 60601 1 2 Expected working life A life expectancy of 10 years is declared This device it a Clan lla medical dewice according ta the European Directive 93 42 CEE 15 46 DESCRIPTION OF THE DEVICE Spirolab is a new generation spirometer it facilitates the total valuation of lung function The product is designed for use by specialists who require a simple compact device but one at the same time capable of calculating more than 30 spirometric parameters
18. c farts oxygen or nitrogen at Gis aie Mec cee eg Wind sources of heat or cold diut wn rays or other rome a Ukiah titi E E E BO EE AE A D ETN Who must can make the installation The device requires installation by qualified personnel It is the responsibility of the user of the device ta insure Hat the required optrations art wade Subject effect on the use of the device A spirometry tust should only be carried out when the subject is at ret and in good health and thus in a witslle condition for the teat A spirometry tet equines the collaboration of the subject nnee the whject must make a complete forced expiration in order to have a mtaminglul tert uult Limitations of use Contraindications An analytic of the nulti of a piromelry tet is not by tell sufficient to make correct diagnos of the whject s clinical condition A detailed clinical hittery of the abject is also nquind together with the nulti of any other testli wggerted by a doctor Tet comments a tet interpretation and msgid courses of treatment must be gwen by a doctor ny symptoms that the subject bas at the time of the tert must be cardully considered before a spirometry teat in made The war is sponsible to asun both the mintal and the physical capacity of the whject ta make a cord tut and the user must alsa arun the The nccypiablily of a tut is the reponsibility of the usr Special attention should be given ta tating elderly subjecta children and handicapped people The dev
19. cally checks the condition of the battery e After 10 minutes the charging starts and proceeds to full charge e When charging is completed the orange LED turns off and the green LED lights up lt ia possibile Hat during batery charing there may be a bight incuan of a few degrees in the temperature of the power wpply During charging place Spirolab on a suitable bard surface with at least 30 cm of apace all around the dice Switching on the spirometer Lift the LCD display release the catch Press the red on off key on the upper left corner of the keyboard When the device is on the green led on the right hand side of the on off key should light up Backlight settings To adjust the backlighting of the display use the double key EET Press several times as required on the left to diminish the brightness or on the right to increase it Contrast settings To adjust the contrast of the display according to the angle of vision and the surrounding light use the double key ETOH Press several times as required on the left to diminish the contrast or on the right to increase it Loading the thermal paper Open the lid of the thermal paper compartment and remove the paper roll holder Insert the new roll of paper onto the paper roll holder Push the paper into the slot located under the traction reel black rubber reel A sensor detects the paper and automatically advances it The paper will advance to the tearing line Insert the pa
20. cancel the current calibration factor and thus reset the calibration factor to the original value set by the manufacturer enter 0 zero in the space reserved for the FVC and FIVC values ep T A E E E In any cart if a calibration must be made consider the following i 1 If lt 3 L syringe in und to mada the calibration and if the mackine is cortctly calibrated then the FVC aypinge valut will le 3 00 FVC x 1 026 BIPS 3 08 L BIPS for mor information om BIPS see the relevant note 2 If the ambient temperature ia 20 C the value of the FVC syringe value will be 3 00 FIVC x 1 102 BIPS 3 30 L BTPS The user should be aware that the volume of the syringe meaaurtd by the machine is commuted automatically ta BIPS conditions and therefore the nulti compared to the expected values dats not constitute an ner For instance if the calibration is carritd out with a 3L syringe and the measured data is FVC 3 08 and FIVC 3 30 at an ambiunt temperature of 20 C the spirometer ia prrfectly calibrated and the ulatine cornction factor are null Na calibration is required This does not constitue an enon but it in a Logical consequence of what bar bun explained above Printout header text To insert a line that will be printed at the beginning of each spirometry report Change DATE TIME To change the date and time The time is shown in the 24 hour format Choose operating language To modify the language of the device Choose
21. ckaging to return the machine to your local distributor or to the manufacturer Due to ongoing product development and product improvements the manufacturer nuwes the rit to modify the to your requirements as described and or from the keybord graphics Copying of this manual in whole or in part is shictly forbidden The manufacturer accepts no responsibility for lor or damage dut ta the uu of thin manual and or dut ta an incorect 2 46 IMPORTANT NOTE I the device needs to be returned for repair the following steps must be followed before sending the unit witen porminion for return must be obtained from the manufacturer with a Return o the delivery must be prepaid by Ue undu Manufacturer s address MIR srl Via Del Maggiolino 125 00155 Rome Italy Tel 39 0622754777 Fax 39 0622754785 e mail mir spirometry com 3 46 INDEX INTRODUCTION INTENDED USE User category Qualification and experience required Operating environment Who must can make the installation Subject effect on the use of the device Limitations of use Contraindications IMPORTANT SAFETY WARNINGS DANGER OF CROSS CONTAMINATION The turbine The mouthpiece PROBLEMS AND UNFORESEEN ERRORS LABELS AND SYMBOLS Other symbols on the device TECHNICAL FEATURES OF THE DEVICE Parameters measured Technical specifications DESCRIPTION OF THE DEVICE ILLUSTRATION OF Spirolab ILLUSTRATION OF Spirolab Il KEYBOARD ILLUSTRATION OP
22. d cance inrtparabile damage ta the turbine Move them briskly inside the solution in order to remove any impurities contained both inside and outside of the pieces Leave them immersed for the time specified in the instructions of the solution Rinse well in clean water and do not expose the turbine to a direct jet of water 42 46 Let the water drip off of the turbine and the mouthpiece holder by shaking them and then put them to dry on a clean surface in an upright position When the two elements are dry insert the turbine into the mouthpiece holder and then insert them into the optoelectronic sensor To avoid ambiental contamination caused by the disposal of the cleaning and atvriliging solutions the user must follow all local aeyulations Verify the free movement of the turbine e Switch on Spirolab as if to make a spirometry test for example FVC e Hold the optoelectronic sensor in one hand and move it gently from side to side so that air passes through the turbine e If the rotor within the turbine is turning correctly then you will hear a beep that indicates that the turbine is moving within the specific low flow range indicated by the beeping e If moving the turbine from side to side at a constant velocity the regular beeps or no beeps at all are heard then proceed with the cleaning of the turbine 43 46 Nolen win pee F aca Waal Capacity Jaaa Siaga frisk uber jmi bes Coige EO Tv a agaw HT ii pom JE oe pi j
23. e cleaning operations as outlined in the MAINTENANCE CLEANING AND STERILIZING section of the manual Switching off the spirometer After a few minutes generally about 5 min that the device is not used then the device automatically turns itself off in order to reduce battery consumption In any case if the device remains switched on when all operations are completed switch it off by pressing the red on off key When the device is switched off the green LED indicator on the right hand side of the on off key should also turn off When there is no need to charge the battery detach the power supply from the power supply socket on the back of the device and remove it from the mains socket 23 46 SPIROMETER FUNCTIONS Spirolab makes the following spirometry tests Fvce Forced Vital Capacity test Slow Vital Capacity test Maximum Voluntary Ventilation test The valuation and interpretation of test results are given by comparing the measured parameters with specific normal spirometry values known as predicted values which are calculated from subject data age height weight sex and ethnic group For the calculation of the normal spirometry values there are five different sets available both for adults and for children e for adults ERS European Respiratory Society Knudson Morris Bass Multicentrico Barcellona e for children Knudson e for children Zapletal After each test session the results a
24. ed to MIR MIR reserves the right to modify the instrument if required and a description of any modification made will be sent along with the returned goods 46 46
25. ey will be activated in a future release of the internal software Q Specifies female sex Specifies male sex Insert or modify subject data Configuration menu es View best test result View last test result 19 46 View bronchodilation test Print Cancels the current operation VC Make FVC test ce Make VC test vv Make MVV test Make POST test MEM Memory management of spirometry data Help key will be activated in a future release of the internal software EN w d D Move cursor and or move within a page 20 46 OPERATING THE SPIROMETER First check that all accessory items are in good condition Before using the device proceed with the cleaning and sterilizing operations as described in the MAINTENANCE CLEANING AND STERILIZING section Charging the battery Make sure that the electrical information found on the label of the charging unit corresponds to that of the mains power Plug the power supply into an electrical outlet Plug the power supply jack into the socket on the back of the device Do not use the power supply if it is wet or damp The charging process has several phrases which are signalled by two LEDs one green and one orange e Immediately after connecting the power supply the orange LED on the right hand corner near the battery symbol starts to flash e After afew seconds the orange LED stops flashing and remains lit e For about 10 minutes the charging is only partial and the device automati
26. f and conwlt the inttuction manal De not open or tamper with the device 7 46 Use of non original parts ach as the turbine flow umor and other sceenorin may care inom in measurement and or The installation must be carried out according to the manufacturer s inttructions An incoruct initallation may caus damage ta people animals or things in which the manufacturer is not ta be considered Lable Any modifications adjustments repairs or rtconfigoration must be made by the manufactur or by pensonn authorized by the In case of problems never attempt ta make repaint by oneself The set up of the configurable parameters should only be made by qualified perenne However an incorrect set up of the Inadequate rnepect to any of the above mentioned pointi may compromise the safely of the device Always reapect the safety norms indicated for electrical devices in particuler uu only original aceerrorinn and apart ports de not immi the dice im any type of quid he not touch the device with wet or damp bands da not leave the device expound to clmoypberic condition when unplugging the device never pull the cable of the power supply or of the device o alway place Spirolab on a suitable rigid horizontal on a stable yace with at least 30 cm of apace all around the device The ventilation lotr must be fre from any cover or cbitruction of any ind The ventilation soti ane located both bebind and underneath the plastic outer caring of t
27. he device Before plugging in the charging unit make wre that the electrical information on the label of the charing unit conrtpords ta hore of the ectriical wiring of the mains supply In care the plug of the charging unit supplied with the device in not compatible with the dechre rocket of the mains apply call cables I it ia erential to use them it in mecerrany ta utilize only types that conform to the safety norma paying attention that they Unplug the power supply cable when battery charging is not required In care of breakdown or damage of the charging unit replace it only with the marufacturtr s original spare ports In order to avoid dangerous overheating we recommend to totally unwind the power apply cable of the charging unit The maintenance operation detailed in thin manual must be carried out pucisely lf Mere instruction are net followed ha can canu marrmend tron and or incorect tut interpretation Before doing any cleaning and or maintenance operations always witch off the device and unplug the power supply When deciding ta no longer use the device it in commended ta dispon of it according ta the local regulations 8 46 In order ta avoid contamination of the vironment provoked by disposing of the pirometnr of its accenrorits of plastic conmmalle materiala or ports follow all local ugulations Da not uu the product for Longer than the declared life expectancy I the LED of the Lithium backup battery flasher the
28. ice should never be used when it in porrille or probable Wat the vadility of the usulli may be compromised due ta any suck 6 46 IMPORTANT SAFETY WARNINGS Spirolab has been examined by an independent laboratory which has certified the conformity of the device to the European Safety Standards EN 60601 1 and guarantees the EMC Requirements within the limits laid down in the European Standard EN 60601 1 2 The Spirolab is continually controlled during its production and therefore the product confirms to the established security levels and quality standards laid down by the Council Directive 93 42 CEE for MEDICAL DEVICES After removing the device from ite package covtrel that there ia ne visibile damage puurt pay particular atenton ta any flaws or cracha in the plastic caring that may lead to report of electrical components and Lams Consewe the imstructions for wie together with the warranty conditions for any future reference or im cane the device puurt technical problems The device must be uud only and exclusively as a pirometer following the indication gwen by the manufacturer with particular atenton to the paragraph on INTENDED USE atibizing only original spare parts and acetnorins Any use of the device which differs rom the original is ta be comridered improper and therefore dangerous The manufacturer cannet be held rerponsible for damage caused by the failure of the user ta follow there inttwuctions coructly minute of the device
29. ion of the subject is normal then the following message is shown Normal Spirometry If there is insufficient data for the interpretation to be calculated then the following message is shown Not Valid ATTENTION THE INTERPRETATION MADE WITHIN A TEST SESSION FOR ANY SUBJECT IS ALWAYS BASED UPON THE BEST TEST MADE IN THAT SESSION BY THAT SUBJECT 26 46 INSERT MODIFY NEW SUBJECT DATA Press key CHANGE NEW Modify the details of the current subject or enter the anthropometric details of the new subject FIRST NAME BIRTH DATE 04 05 71 H EI GHT cm Kg SPI ROMETRY INTERPRETATI ON CHOOSE ANY FUNCTI ON The cursor blinks on the ID code Enter code via the keyboard ID code must be confirmed with or cancelled with canc To change a number after it has been entered use key to return the cursor to the area required Enter the subject ID code this can be a combination of 10 characters with which it is possible afterwards to recall the subject test details AGE Enter the subject s age in years 1 99 with keys 9 SEX Select gender using the keyboard for male and EA for female HEIGHT Enter the subject s height in cm or in inches according to the current configuration WEIGHT Enter the subject s weight in Kg or in pounds according to the current configuration ETHNIC GROUP A list of possible ethnic groups appear By relating a subject to an ethnic group the predicted values for that subject
30. lithium battery in uud for the back up of the test data and yiromthy parameter in the memory plus the device configuration which indicates at the battery ia low then all information toud may be cancelled The bateriu used for power apply and for data storage are both inside the device It in not permitted to open the device in order ta aiplace them This procedure must be carried out only in an theorind uwice ante thorized by the manufactur 9 46 DANGER OF CROSS CONTAMINATION The device utes a turbine umo and im order ta connect a subject to the spirometer a mouthpicce in required Always us a new In order ta avoid exporing the abject to the critical danger of creur corlamination certain components of the flow umo must always be sterilized before ach piromttry tet The turbine For details of the covet sterilizing operation ue the relevant paragraph in MAINTENANCE CLEANING AND STERILIZATION s described in this manual Do not cepon the turbine umon to a direct jet of water or ain nor allow it to come inte contact with Liquid ot high temperature Da not allow dust or foreign bodies to enter the turbine un in order ta avoid incorrect functioning and porrille damage The presence of amy impurities such as bain putum Urneads de within the body of the turbine umo may wriourly compromise the The mouthpiece Amy disposable mouthpieces included with the device are wpplicd only as a guide ta the coriect type and dimensions of the
31. ng cases e If the fault is due to an improper installation or operation of the machine or if the installation does not conform to the current safety norms in the country of installation e If the product is use in a different way from that described in the User s Manual improper incorrect and or unreasonable use If any alteration adjustment modification or repair has been carried out by personnel not authorised by MIR If the fault is caused by lack of or incorrect routine maintenance of the machine If the machine has been dropped damaged or subjected to physical or electrical stress If the fault is caused by the mains or by another product to which the instrument has been connected If the serial number of the instrument is missing tampered with and or not clearly legible The repair or replacement described in this warranty is supplied for goods returned at the customers expense to our certified service centre For details of these centres please contact your supplier of the spirometer or contact the manufacturer directly The customer is responsible for the transportation and for all transport and customs charges for the delivery of the goods both to and from the service centre Any instrument or accessory returned must be accompanied by a clear and detailed explanation of the defect or problem found If units are to be returned to the manufacturer then written or verbal permission must be received before any instruments are return
32. nical problems always note the version number DATE and TIME The present date and time which can be modified from the configuration menu PRE drug The first test for each new subject is a PRE type ie without the administration of drugs For the POST test ie after the administration of drugs see the relevant paragraph in the POST test chapter of this manual FILE Spirolab assigns a progressive number to each new test PRE and to each POST test that is made on the same person when the dose of the drug is changed ID Indicates the subject number or identification code which is inserted by the user If an existing ID code is inserted the device will warn the user with the message WARNING THIS ID IS ALREADY ASSIGNED TO A SUBJECT CONFIRM THIS EXISTING SUBJ ECT OR MODIFY SPIROMETRY INTERPRETATION Indicates the test interpretation made Automatic Interpretation The functional diagnosis or more correctly the test interpretation carried out by the Spirolab follows the most recent ATS recommendations with 5 levels of obstruction and of restriction plus a normal spirometry diagnosis For obstruction ie reduced flows Very Severe Obstruction Severe Obstruction 25 46 Mod Severe Obstruction Moderate Obstruction Mild Obstruction For restriction ie reduced volume Very Severe Restriction Severe Restriction Mod Severe Restrict Moderate Restriction Mild Restriction If instead the results show that the lung funct
33. nsert the relevant FILE number to view and or to print the corresponding spirometry report LAST NAME FILE PHASE Press to print out the corresponding test s 40 46 FILE ORGANIZATION The memory of the spirometer is a string of memory areas called records each of which contain information regarding a single test session In detail each record is made up as follows Anthropometric details of the subject Date time and ambient temperature at the time of the FVC test Reproducibility and quality control information Parameters stored with the FVC test FVC FEV1 PEF FEF75 FEF2575 FET PEF FVC FEV1 FEV1 FEV6 FEV6 FEV1 FEV6 FEF25 FEF50 Vext FIVC FIV1 FIV1 PIF FEV1 VC e Parameters stored with the VC test VC IVC VC or IVC ERV IC TV VE fr ti te TV ti te tt e Parameters stored with the MVV test MVV e Points of the expiratory part and if made the inspiratory part of the Flow Volume curves then the points of the Volume time curve All of the parameters are always stored wen if not all of the testa were made in this care the uult of thou parameters are stored aa yro The symbol indicates the bert uult of that abject Spirometry results can be recalled from the memory To go into the database press the key and select the required record based on the FILE number or on the subject ID code The results of the selected test can be printed by pressing the key while viewing them 41 46
34. nt of the turbine ON LINE OF SPIROLAB II WITH WINSPIRO SOFTWARE PROBLEMS CAUSES AND SOLUTIONS LIMITED WARRANTY CONDITIONS 5 46 Pg Pg Pg Pg Pg Pg 30 Pg Pg Pg Pg Pg Pg Pg Pg Pg Pg Pg Pg Pg Pg Pg Pg Pg Pg Pg Pg Pg Pg Pg Pg Pg Pg Pg Pg 28 28 28 28 29 30 30 30 31 32 33 34 35 35 36 36 37 37 37 37 37 37 37 38 38 38 39 40 40 40 41 44 45 46 INTRODUCTION The spirometers series MIR 010 are sold with the Spirolab and Spirolab Il names The difference between the two models Spirolab and Spirolab Il is that the Spirolab II model includes an LCD colour display and a full International Alohabet Keyboard with 29 characters In the Spirolab model the display is in Black White and the keyboard does not include the 29 International Alphabet characters not otherwise specified from this point onwards for sson of brevity Spirolab is uud in reference to both models INTENDED USE User Category The spirometer calculates a series of parameters relating ta human spinator function The product ia therefore intended for wie by a doctor or by a paramedic under the wpewition of a doctor Qualification and experience required The correct vue of the device the interpretation of the tet uult plus the maintenance of the device in particolar the Anriilystion te Operating environment ae ee ee anatitheli
35. o BIPS conditions 3 C must be increased by 2 6 This is derived from the BIPS factor of 1 026 at a temperature of 33 C In practice the BIPS factor for the expired flow and volumes is therefore fixed and equal ta 4 026 For the inspired volumes and flows the BIPS factor depends upon the temperature of the ambient ain impired For example at an ambient temperature of 20 C the BIPS factor ia 1 102 ie a correction of 40 2 The convertion of the imapined volumes and flows is made automatically as the machine bia an internal temperature semo and the BIPS values are thus caleulated It is possibile to insert the volume in cL of the calibration syringe used for a 3 litre syringe enter 300 cL 37 46 Insert both the FVC and FIVC values measured in a test with a calibration syringe The coefficient correction factors now are calculated and shown If they are lt 20 the new correction are shown lf the percentage is greater than 20 the display shows Error out of range To indicate that the system is not able to correct such a large calibration error When a new calibration i4 made then the new correction factor will be added to the existing factor if any The display shows the previous calibration Previous with the FVC and FIVC values and the percentage differences diff If no calibration has ever been made then FVC and FIVC are equal to the nominal value of the syringe and the percentage differences are null To
36. per roll holder into the appropiate slots Close the lid of the compartment The paper must advance through the slot in the compartment when it is closed If necessary make the paper advance forward by pressing the key To avoid dammace ta the printer and or defects im printing it is commended ta always ue thermal paper wth 112 mm width righ 21 46 The sensibility of the thermal paper must be suitable for printers with a printing speed of SO mm s This type of paper is tary ta find Connecting the flow sensor The flow sensor is made up of the elements shown in the following illustration optoelectronic turbine mouthpiece mouthpiece sensor holder Before doing any spirometry testing be sure that there are no foreign bodies present inside the flow sensor Attach the connector of the flow sensor on the left hand side of the Spirolab Make sure that a new diposable mouthpiece has been correctly inserted into the mouthpiece holder as shown 22 46 Detail of the flow sensor compartment Carefully follow all the instructions given in the various paragraphs of this manual to ensure that all of the functions operate correctly Remove the used mouthpiece and dispose of it after finishing the spirometry testing When the flow sensor head is not in use we recommend that it is kept in its compartment Press lightly on the connector to detach the flow sensor turbine from the socket on the left hand side of the device and proceed with th
37. ratio between the measured value and the predicted value 30 46 SPIROMETRY POST DRUG TESTING 1st case current subject After one or more PRE tests to make a POST test on the current subject proceed as follows Press key to activate the POST phase A POST test can be made immediately 2nd case subject from FILE To recall a subject from memory in order to make a POST test you must first recall from memory the corresponding PRE test of that subject Proceed as follows Press MEM Select either Subject List or Memory List to list the relevant PRE test and then select the FILE number of the PRE test to use for the POST test Then press to activate the POST phase Note that when the POST phase is active the data of the existing subject test are shown on the display On the upper left appears the POST file number During the POST phase it is possibile to make FVC VC and MVV tests Before making any of the POST tests Fv ve the device requests the input of the drug dose Insert the dose with the numerical keys and confirm with Bia Whenever the test is repeated using the same dose the best test related to the dose used is memorized When the dose is changed then a new record is made with a progressive FILE number For example if three different doses are used for the same subject then three different records POST tests are made for that subject Afterwards it is possible to view the separate best POST test
38. re compared to the relevant predicted values and the percentage ratio between measured and predicted is shown for each parameter Predicted Measured Predicted x 100 The test can be repeated more than once and the best result is memorized in order to recall it from the Spirolab s memory The best test result is determined following the ATS American Thoracic Society and ERS European Respiratory Society standards as described in APPENDIX B All tests are analyzed by applying six quality criteria quality control following the latest ATS recommendations In addition the reproducibility of the FEV1 FVC and PEF parameters are also calculated It is possible to make POST drug testing in this case the test results are compared to a test made prior to the administration of drugs PRE Test from memory Spirolab visualizes and prints the two Flow Volume and Volume time curves superimposed with PRE and POST parameter comparison and percentage of change PRE Value POST Value PRE 100 The sections of the manual written with the character tyoe SPIROMETER represent the display of the device 24 46 FIRST NAME BIRTH DATE HEI GHT CHOOSE ANY FUNCTI ON After switching on the current date and time is shown the time of the last calibration control is printed and the opening screen appears Some values shown are as follows V X Y Indicates the version of the software firmware inside the spirometer In case of tech
39. ropiate keys regulate the brightness and the contrast of the display The battery charging is not working correctly The device is protected thermically In case the power supply of the battery reaches high temperatures then a thermal protection intervenes and prevents the charging This thermo protector can intervene if e the device has operated over the functioning limits indicated in this manual e the device is operated near a heat sources or in ambients with a temperature either too high or too low Disconnect the power supply and let it cool down before continuing with charging The lithium battery for the data memory indicates discharged If the internal lithium battery is discharged the spirometry parameters in the memory and other configuration data may be cancelled automatically Call an authorized service centre to replace it The printer does not print The thermal paper may have run out Insert a new roll of thermal paper The printer is in thermal protection The printer is also protected thermically In case the printer reaches elevated temperatures then a thermal protection device intervenes and blocks the functioning of the printer A message on the display appears to signal the protection Let the printer cool down before turning on the device again The printer makes noises Make sure there is a sufficient quantity of thermal paper Make sure that the thermal paper and the thermal paper holder are positioned correctl
40. s The subject code in the POST test is the same as for the related PRE test In the POST phase the measured result is compared to the values of the relevant PRE test made before the drug administration The Flow Volume curves of the PRE test and related POST test are shown on the same graph When the two curves are shown press the key to proceed to the viewing of the measured parameters POST of the related PRE values and the percentage variations between POST and PRE In the POST phase no test interpretation is given the tut quality control menage are shown Physiological Test placebo It is common practise prior to a POST test to make a test using physiological solution in place of a drug to examine the subject s response to such a stimulus If the subject is healthy the reaction to a placebo is almost zero but in the case of hypersensitivity even this stimulus can cause some reaction In the physiological test the amount of the dose to enter is zero and it is still possible to compare the POST results with those of the PRE test 31 46 VIEWING AND PRINTING THE RESULTS From the main screen it is possible to view and print the following Press OR for results plus Flow Volume curves relating to the best test Press key for results plus Flow Volume curves relating to the last test All tests in memory can be recalled viewed and printed The test results in the memory are the best test results The current test result can
41. the test is interrupted and the device returns to the main screen The key 4 or the lack of a volume variation for more than 3 sec will terminate the test How to make spirometry testing Insert the new mouthpiece into the mouthpiece holder Fit the noseclip tightly onto the nose of the subject to ensure that air cannot escape through the nostrils The mouthpiece must be inserted well into the mouth beyond the teeth and the mouth must be closed around the mouthpiece to ensure that air cannot escape from the sides of the mouth Breath as directed according to the test required details as follows Make the test in a standing or a sitting position During total expiration slowly or forced it is suggested to bend forward at the waist as this movement helps to force air out of the lungs FVC If required this is optional before the test make several breaths at rest When ready inspire slowly as much air as possible opening the arms helps and then expire all of the air as fast as possible Then without removing the mouthpiece from the mouth finish the test by inspiring again as fast as possible This final inspiration is not necessary if the inspiratory parameters FIVC FIV1 FIV1 PIF are not required It is possible to repeat the cycle several times without removing the mouthpiece and in this case Spirolab will automatically select the best test and will show the results To end the test press or wait 3 sec after the last volume cycle
42. trapolated volume Vext is greater than 250 mL or more than 5 of FVC or when the PEFT time to peak flow is greater than 200 ms this message is shown repeat the test and blow faster DROP IN FLOW gt 50 lf there is a drop in flow gt 50 and the flow then rises again all within the 1st second of the expiration this message is shown repeat and avoid coughing FET ERROR If the FET is less than the minimum this message is shown expiry time insufficient FLOW ERROR If the last point of the F V curve is greater than 200 mL s this means that the expiration was not finished and therefore this message is shown blow out all air in the lungs 33 46 REPRODUCIBILITY OF THE FVC TEST Following the international ATS and ERS standards it is recommended to repeat at least 3 times every FVC test to ensure the reliability of the spirometry test results The device helps the user through the reproducibility control check Between one test and another the reproducibility of the following parameters is calculated FVC gt reproducible if AFVC lt 5 or lt 200 mL FEV1 gt reproducible if AFEV1 lt 5 or lt 100 mL PEF reproducible if APEF lt 10 A delta indicates the difference between two measured values At the end of an FVC test the reproducibility of a single parameter is indicated alongside the numerical value by a sign reproducible or a sign not reproducible An FVC test is defined as reproducible when
43. y Make sure that the thermal paper container lid is in the correct position The device does not measure Make sure that the turbine s cable is connected to the spirometer and that the plug is inserted properly in the appropiate connector Make sure that the turbine is inserted correctly into the optoelectronic holder The device does not measure correctly Make sure the turbine is inserted correctly in the optoelectronic holder Carry out the Control of the turbine free movement illustrated in the relevant paragraph in the maintenance chapter In case the device dors not resume correct functioning im yite of the controls made call the manufactur or an muthoriyped wie eentu 45 46 LIMITED WARRANTY CONDITIONS This MIR product together with its standard accessories is guaranteed for a period of ONE YEAR from the date of purchase In the case of any warranty claims the relevant sales invoice or another proof of purchase document must be submitted to MIR The instrument must be checked at the time of purchase and any claims must be made immediately in writing to MIR This warranty covers the repair or the replacement at the discretion of the manufacturer of the product or of the defective parts without charge for the parts or for the labour All batteries and other consumable parts are specifically excluded from the terms of this guarantee The warranty is not valid and the judgement of the MIR technicians is final in the followi
44. you have the reproducibility for at least the FVC and FEV1 parameters 34 46 METHOD OF MEASUREMENT AND INTERPRETATION The device uses the infrared interruption measurement principle with two sets of optoelectronic transmitters and receivers A pair of deflectors positioned at the entry and at the exit of the turbine tube generates a vortex around the axis of the sensor in the passing air A rotor with a speed of rotation directly proportional to the air flow then interrupts the the infrared beams and generates a signal The measurement of the air volume that passes through the tube is proportional to the interruption of the infrared rays This measurement principle guarantees stability reproducibility and reliability over a long period of time The measurement is not effected by gas density humidity or pressure The cleaning of the turbine flow sensor is very simple and essential for the protection of the subject from possible infections For cleaning and sterilizing operations see the relative paragraph of this manual No calibration of the turbine is required but it is good practice to make a calibration check see the simple instructions found in the relevant paragraph in the maintenance section of this manual Method of test interpretation Following every FVC test the device makes a quality control check to verifiy the validity of the test made and also if possible a test interpretation by comparing the main measured parameters
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