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Spirolab User manual Rev. 1.3 Date issued 12.03

1. entries using the virtual numeric keyboard on the screen Tapping the les A i A Su ie a j ney Om Oo Aa a a Ethnic group field brings up a drop down menu where you can choose the desired value The icon allows you to delete the last character entered afofofifojo The icon Lo allows you to enter uppercase characters QUyWFEFREITTY PUT Torr 172 3 od The icon allows you to enter information in the next field ES Es E E be E amp 21915 lt gt ZUlxlcivibinimild 711819 A l l The icon EY allows you to save your entries and return to the main screen E hn 70 A WARNING The data required to create a patient profile is name surname sex Page 18 of 34 MEDICAL INTERNATIONAL RESEARCH Spirolab In the Ethnic group field the following options will appear No group selected 100 Caucasian Caucasian 100 Afro American Oriental 100 Mexican American Hong Kong Chinese 100 Others Japanese 89 Polynesian 90 North Indian 90 South Indian 87 Pakistani 90 Of African descent 87 Aborigine 85 In the case of ATS ERS standards depending on the ethnic group set the correction percentage acts on the theoretical values of the following parameters PVG FEV 1 FEVS PEVO FIVC FIV EVE IG VG ERV TV TY74 In the case of NHANES III standards depending on the ethnic group set different theoretical formulae are t
2. on N O N e Q Ow 7 1 i h T i 7 7 o gt i gt e 2 2 Z 2 10 1 Interpreting spirometry results The interpretation of spirometry refers to Forced Vital Capacity FVC and is seen by means of indicator lighting The messages can include the following Page 230834 MEDICAL INTERNATIONAL RESEARCH 4 Normal spirometry 4 Slight obstruction restriction 4 Moderate obstruction restriction Spirolab 4 Moderately severe obstruction restriction 4 Severe obstruction restriction 4 Very severe obstruction restriction The final interpretation level is restriction obstruction where the indicator light indicates the worst parameter between restriction and obstruction Thanks to a mathematical analysis known as quality control that is applied to some indices and parameters calculated in FVC tests the spirolab device can produce different comments that help to understand the reliability of tests carried out The quality control system uses letters as described below 1st case PRE test A at the end of two acceptable tests the variation of the two highest FEV1 values and the two highest FEV6 values are less than or equal to 100 mL B at the end of two acceptable tests the variation of the two highest FEV1 values is between 101 and 150 mL C at the end of two acceptable tests the variation of the two highest FEV1 values is between 151 and 200 mL D only one test was acceptable or there is more than one accept
3. sealed packaging Disposable turbines are made of plastic to dispose of the turbines please comply with local legal requirements Reusable turbine A WARNING The correct use of a reusable turbine is guaranteed only and exclusively if it is clean and free from foreign bodies that alter the motion of the blades If a reusable turbine is not properly cleaned it can cause cross infection between patients Periodical cleaning of the device is only sufficient if that device is used exclusively by the same patient For further details about cleaning refer to the appropriate section in this User Manual The following information is valid for both types of turbine Never expose turbine sensors to jets of water or air or allow contact with hot liquids To avoid malfunctions or damage do not introduce dust or foreign bodies into the turbine sensor The presence of foreign bodies such as hairs saliva etc inside the turbine flow meter can compromise the accuracy of readings 1 2 3 Mouthpiece The single use mouthpieces that come supplied with the device are provided as a sample to demonstrate the correct type and size They must be considered clean but not sterile We recommend that you contact the local distributor where you bought your spirometer to obtain additional mouthpieces These are usually made of cardboard or plastic and are always for single use only A WARNING Use biocompatible mouthpieces to avoid pro
4. Humidity MIN 10 RH MAX 95 RH Humidity MIN 10 RH MAX 95 RH Temperature MIN 10 C MAX 40 C Humidity MIN 10 RH MAX 95 RH oca sandari Electrical Safety IEC 60601 1 PP Electro Magnetic Compatibility IEC 60601 1 2 Key performance in accordance with Accuracy in measuring spirometry parameters in accordance with the ATS standard EN 60601 1 2007 Measurement of oximetry parameters with accuracy as defined in the table on page 13 Ze USING THE SPIROLAB Storage conditions Operating conditions 2 1 Turning the spirolab on and off To turn the spirolab on press then release the button on the front of the unit 02 09 2014 12 22 Ver1 0 When you turn on the device the first screenshot shows the internal software loading progress The display will automatically display the main menu after a few seconds Loading Page 13 of 34 INS MIR INTERNATIONAL RESEARCH Spirolab D Martini Age40 180cm 75 kg Male 02 09 2014 12 22 Ver1 0 J fr ADD SEL Turbine Reusable BTPS 1 082 Predicted in use File 1 ERSIKNUDSON Free Memory CANA A POW Ew En u ea am MODIFY FVC vC o Mw J DATA OXY DATA _ PRINT To turn spirolab off press the power button on the front of the unit A WARNING Spirolab does not turn off completely but enters an ultra low standby mode some features remain active to allow the device I to keep the date and time updated and to be activated remotely if required For thi
5. On completion of the test tap A a During the test the spirolab emits repeated beeps the frequency of which is directly proportional to the speed at which air is being inhaled and exhaled This helps the doctor understand when the rate of air flow is approaching zero and therefore when the patient has exhausted the volume available in exhalation and inhalation The section dedicated to maintenance also describes how this feature is also useful for easily checking that the volume and air flow sensors are working properly Apart from requiring a deep exhalation of breath for the results of an FVC test to be reliable the Forced Expiratory Time FET must also be long enough to allow the complete expulsion of all the air in the lungs 2 9 2 VC test wih VC Ventilatory profile You can start testing Slow Vital Capacity by breathing at rest After three or four similar consecutive breaths a continuous beep warns the user that the ventilatory profile has been measured and that VC or IVC can now be measured Slow Expiratory Vital Capacity VC After the beep nhale as slowly as possible and subsequently exhale as slowly as possible Slow Inhalatory Vital Capacity IVC After the beep exhale as slowly as possible and subsequently inhale as slowly as possible ei On completion of the test tap se 2 9 3 MVV test Ww Start the test with a series of forced inhalations and exhalations at the fastest speed possible The recommended frequenc
6. Oximetry Riference Delete results Calibration For calibration see paragraph 2 5 1 below Oximetry In this section you can configure all alarms related to an oximetry test By setting the desired alarms to ON you will activate a box where you can set the relevant threshold value using the numeric keypad Spirometry SETTINGS 02 09 2014 12 22 Ver1 0 Device Calibration Riference Delete results A WARNING If the maximum value of a parameter is less than or equal to the minimum value the setting process will not proceed A beep will sound and the device will automatically return to the screen for setting the minimum value References This section allows you to set the theoretical value used between ERS Knudson Knudson Knudson USA Knudson ERS Zapletal MC Batcelona Zapletal JRS JAPAN JRS JAPAN Page 16 of 34 AN MIR MEDICAL INTERNATIONAL RESEARCH Spirolab Usermanual Pereira Pereira CECA1971 Knudson Wang Hankinson NHANES III If you choose the last theoretical value Wang Hankinson the limitations provided for in the past by the standard NHANES III will be applied A WARNING If you set the theoretical value Wang Hankinson are disabled the VC and MVV tests Delete archive Using the numeric keypad enter the following code to permanently delete all the tests stored in the device 122333 2 5 1 Calibrating turbines A WARNING The turbine does not nee
7. e Configure the device date time assigned values language etc as described in section 2 5 A WARNING Before connecting spirolab to a PC install the winspiroPRO software supplied with the device Once the software has been correctly installed connect the device to the PC a message will appear that confirms the recognition of a new peripheral device Keep the original packaging In the event of a problem with the product use the original packaging and send it to your local distributor or to the manufacturer If the device is being sent for repair the following rules apply e Goods must be sent in their original packaging e Costs involved in sending the product are at the sender s expense Manufacturer s address MIR SRL VIA DEL MAGGIOLINO 125 00155 ROMA ITALY Tel 39 0622754777 Fax 39 0622754785 Website www spitometry com Email mir spirometry com MIR implements a policy of constant product improvement and the technology we use is in a state of continuous evolution For this reason the company reserves the right to up date these instructions if necessary If you have any suggestions that you consider useful please send an e mail to the following address mir Wspirometry com Thank you MIR does not accept any responsibility for any harm or damage caused by users failing to follow the instructions or failing to heed the warnings in this manual Total or partial copying of this manual is forbidden 1 I
8. 800 MHz the highest frequency interval is applied NOTE 2 These guide lines may not apply for all situations The propagation of electromagnetism is influenced by the absorption and reflection of structures objects and persons a The intensities of fixed transmitter fields such a telephone base stations mobiles and cordless terrestrial radio equipment amateur radio appliances AM and FM radio and TV transmitters cannot be theoretically accurately predicted To assess an electromagnetic environment generated by fixed RF transmitter you need to perform an electromagnetic scan of the site If the intensity of the field where the SPIROLAB is used exceeds the applicable conformity level mentioned above you will need to observe how the SPIROLAB works under normal conditions If you detect faulty performance you may need to implement additional measures such as changing the direction or position of the SPIROLAB b The intensity of the field in the frequency interval from 150 kHz to 80 MHz should be less than 3 V m Recommended separation distance between mobile radio communication appliances and devices SPIROLAB devices are designed to work in electromagnetic environments in which radiated RF disturbances are controlled The device customer or end user can contribute towards preventing electromagnetic interference by providing a minimum distance between mobile RF communication devices transmitters and the unit as recommended below in relation to
9. INTERNATIONAL RESEARCH Test with bronchodilator POST Spirolab m To end a test tap seen 2 9 1 FVC test D FVG To perform an FVC test follow the instructions below INHALE all the air EXHALE forcefully 26s INHALE forcefully The test can be started optionally by breathing at rest When you are ready inhale as quickly as possible it is easier if you open your arms wide and expel all the air in your lungs with as much force as you can Without removing the mouthpiece complete the cycle by inhaling as quickly as possible The latter step can be omitted if calculation of the inhalation parameters FIVC FIV1 FIV1 PIP is not required The inhalation stage can also be performed before putting the mouthpiece in your mouth Following a slow deep intake of breath the next exhalation should be performed with as much force as possible and as quickly as possible After 6 seconds of exhalation the device will emit a continuous beep that tells you that the minimum exhalation time has passed This is the minimum time required by the main International Pulmonology Associations A WARNING Remember that for accurate spirometry results it is essential that all the air is expelled from the lungs The test can be repeated as often as required without the mouthpiece having to be removed from the mouth In this case the spirolab will automatically recognise the longer cycle longer FVC FEV1 and present the relative readings
10. O IGN rs ii 9 1511 o e da el sd e nie E E E E NET 9 1312 Symbol FOr Teac Ne the Ope anno stru ONS alrededor dvi rise 9 1 4 area o I sng es inl ae eco ae O AAN tle II A E 10 13 TES GIS ANS APP nial EA ASO E O E O 11 LL SO pendones cde geet sede acco E EEE oe aca cect aetna E E E E E 11 home PMR Sf Ue OG ado dc bell cea wr AE ide ih es RR erases 12 Eo A o A en ead fe omen E EE oa eea NANA 12 za UNS a i rc 13 2 1 dea E EE A A on un o E 13 2 2 Sabare CICLO Ir e a O 14 Zo CE PP A A A IA 14 2 4 iA ICONS asion teh A o PO e e E E E o 14 Ze esa TMi OR O o a ep E scala OCRE E CO T A O POC bag bates E A dane Men ninee oes eg proccess 15 al Calbraino ura eve ok ia E 20 an patience E ce acd gta NA A A A o Au o o A I A eas 18 Ll E E A A E A A NN ARA A T RN 18 AA E A A o OO E E S E 19 gk VERE SEORCO CALA EEE ninssunctnsishiasinaeosinan AAA NAO AAN A 19 P A O e enel tage a PI EP O e OPC O arent aoa E 19 PRT oda AAA oo e PE rn A N AT A 20 Sho Dopa NSC eses ON AAA A AA AA AAA AAA 20 2 8 Online tmode connected to a PO DAS AAA A Tetra 21 de dra dee CDV aleg adoos 00 at ci IOPOO NOAA ORO Ca POCO A e O me Ure a Tom nore ay er ter err ten rr Cavern 2i A A er O re E T ee ee ee 22 PA P LE A o E E A 5 e o rn 22 PA O A O OE ERP E O leh dates E E E E E T E 22 29 4 Running POST tests atter the administrati n 0 La OO aio ieesiere dornuctdolaconctbouunsnebsduasetnleennntoternandatwssmounisteonens dovnuedbilaseunlbcusasnsbsduasete jc tonnmeolecesnibousasueoss 23 210 D
11. Pred 12 22 Ver1 0 PRE ARERAN VEC 1 48 2 31 156 2 04 FEW 1 22 1 15 94 0 90 PEF 90 7 49 8 55 44 1 EvC 1 48 2 04 138 2 04 1 22 0 90 74 0 90 4 02 1 12 28 1 12 1 55 0 67 43 0 38 Interpretation Best values Obstruction a APS eas Normal Spirometry Restriction a EE A ese Quality grade Ripeatability WT J f Vias To view the spirometry tests performed by the selected patient use the icon Sot The information is displayed as in the image on the right On the left you have the test trend in graph form while on the right you have various quality related messages and the values of the parameters selected in the service menu By swiping your finger in the parameter area you can view other parameters selected in the service menu You can delete one of the tests performed as follows tap the column relating to the test data to be deleted the data will be FEV FEVIFVC on fF N ON e WD Ow 7 i 1 h T i 7 7 selected by two bands on the left and right now tap the icon ES on the lower right And tap OK in the popup window which appears on the screen At each screen you can go back to the previous step by tapping ei SAVE SAVEIEXIT 5 7 Aly Di io i gt Saver re Mc oxy Fa V 2 zZz ee D Martini Age40 180cm 75 kg Male 02 09 2014 12 22 Ver1 0 To view the selected patient s oximetry tests use the icon lt o The data is displayed as in the image to the righ
12. collaboration of the patient who must exhale forcefully to ensure that the parameters measured provide reliable results 1 1 5 Limitations of use Contraindications An analysis of the results of spirometry alone is not sufficient to provide a diagnosis of a patient s clinical condition A diagnosis can only be made in conjunction with an examination that takes the patient s case history into account as well as the results of other tests recommended by the doctor Comments diagnoses and appropriate therapeutic treatments are made by the doctor Any symptoms must be evaluated before spirometry is carried out The doctor who prescribes use of the device must first ascertain the physical psychological capacity of the patient to assess his or her suitability for performing the test The same doctor must subsequently evaluate the data gathered by the device to estimate the degree of collaboration for each test carried out A correct spirometry test calls for a patient s complete collaboration The results obtained depend on the patient s ability to inhale and exhale as quickly as possible If these key conditions cannot be met the spirometry results will not be reliable or as doctors say will be unacceptable The acceptability of a test is the doctor s responsibility Extra care must be taken when dealing with elderly patients children or differently able persons The product must not be used if malfunctions or faults are detected or suspected a
13. is directly in line with the detector below it Apply the adhesive tape to the upper part of the finger or toe to keep the sensor in place Run the wire along the palm of the hand or sole of the foot and if necessary tape it in place e Connect the sensor to the device insert the connector with the arrow stamped on the connector facing up and make sure that everything is working properly as described previously WARNING Do not twist the sensor cable without reason or use excessive force when using connecting disconnecting or putting away the oximeter sensor If the sensor is fitted too tightly it may create inaccurate saturation readings It is therefore very important not to make the adhesive tape too tight Page 26 of 34 IN MIR MEDICAL INTERNATIONAL RESEARCH Spirolab We recommend using a sticking plaster to fix the sensor wire to the wrist 3 DATA TRANSMISSION A WARNING Before beginning data transmission read the instructions carefully and make sure you have fully understood them A WARNING Bluetooth communication is considered ad additional function In the event of an interruption in transmission we recommend the use of a more reliable USB port technology 3 1 Data transmission v a Bluetooth Spirolab can be connected as a device to any other mater device Therefore you can connect spirolab to a PC or a mobile phone and control it using special applications The connection uses the SPP Serial
14. or monitoring in the presence of a specialist doctor 1 1 3 Where the device is used The spirolab device was designed for use in doctors surgeries and in hospital wards The appendix to this manual contains the information needed for the correct use of the device in places where electromagnetic factors affect the surrounding environment as required by EN 60601 1 2 The product is not suitable for use in operating theatres or in the presence of flammable liquids or detergents or where there are anaesthetic gas mixtures that become flammable in the presence of air oxygen or nitrous oxide The product is not suitable for use where it may be exposed to air currents e g the wind sources of heat or cold direct sunlight or other sources of light or energy dust grit or chemical substances It is the responsibility of the user to ensure that the product is used and stored under the proper environmental conditions For further information refer to the instructions in section 1 5 3 below WARNING If the device is subject to climate conditions other than those shown in section 1 5 3 it is possible that malfunctions may occur and or that incorrect results may be displayed 1 1 4 Individual patient factors that can affect use of the product The spirometer can only be used when the patient is resting and in good health or at least in a state of health that is compatible with the test being carried out Performing the test calls for the
15. the Printer section you can set the print header on thermal paper Tap the white space under print header to bring up the virtual numeric keyboard You can enter characters until the string is complete O Oximetry BEEBE SO Reference Revs Page 15 of 34 AN MIR MEDICAL NATIONAL Spirolab User manual Spitometry The section is divided into e Parameters 0 Outcome e Incentives SETTINGS 02 09 2014 12 22 Ver1 0 EJ esas Incentive In the Parameters section you can select the values that will be displayed at the end of a test these will be stated on the printout Here too the selection is highlighted by an orange box In the Results section you can choose what to include in the printout from among the following items Calibration Oximetry e Best values eference e Interpretation of spirometry results e F V and V t curves e Only F V EXPIRATORY curve Delete results BEOBBOOR BEBO A A de del ml 1 al A E aed hen d a CI L a E O E O i Oo i E SETTINGS 02 09 2014 12 22 Ver1 0 Enabled parameters In the Incentive section you can configure the paediatric incentive to improve spirometric performance The incentive may be enabled or disabled should it be enabled by selecting ON on the left you must enter the age threshold up to 10 which the incentive is displayed use the numeric keypad on the cajibration g bottom to set this value
16. the spirolab device is turned on an icon shows the condition of the battery in the top right hand corner The maximum charge level is reached when the symbol is completely green If only part of the symbol is green or if the device doesn t turn on you will need to recharge the battery pack as follows e Connect the battery charger to both the connector and the mains supply A blue LED will light up in the lower right hand corner e When charging is completed the LED will turn green Page 29 of 34 MED AL INTERNATIONAL RESEARCH Spirolab S a e When charged disconnect the battery charger from the device and from the mains A WARNING Do not use the device when it is recharging Always disconnect the charger when recharging has been completed 5 TROUBLE SHOOTING AND SOLUTIONS Battery pack may be flat Charge the device using the charger unit l i The device may have lost Connect the device to a PC via USB and up date spirolab doesn t turn on l i internal software the software for further information consult the online winspiroPRO User Manual The data in the device memory If the data has been correctly restored the last Ram error has been damaged standard turning on process will be repeated if not Problems turning the data recovery device on contact an authorised assistance centre or the Please wait manufacturer There is an internal error Check www spirometry com to see if an up d
17. warning symbol should not be touched and connections should not be performed before appropriate precautionary electrostatic discharge ESD measures are undertaken Below are examples of such precautionary measures Environmental procedures air conditioning humidification conductive floor covering substances use of non synthetic clothing User procedures discharge using large metal objects use of an ESD wrist strap Spirolab Any staff that uses devices affected by electrostatic discharge should receive adequate explanations concerning the ESD symbol and adequate training on the effects of electrostatic discharge and on the measures to be undertaken to prevent such effects An electrostatic discharge is defined as an electric charge at rest It is the sudden flow of electricity between two objects in contact an electrical short or a dielectric breakdown ESD may be caused by a build up of static electricity or by electrostatic induction At low relative humidity charge generation will increase significantly due to the dry environment Common plastics create higher charge levels Typical values of voltages caused by electrostatic discharges are shown below Walking on a carpet 1500 35000 Volts Walking on an untreated vinyl floor 250 12000 Volts Vinyl envelopes used to organise documents 600 7000 Volts Worker at a table 700 6000 Volts If two elements have different charge values their coming into contact could cause an electrostatic disc
18. AN MIR Spirolab User manual Rev 1 3 Date issued 12 03 2015 Date approved 12 03 2015 Page lof 34 MEDICAL INTERNATIONAL RESEARCH Spirolab TABLE OF CONTENTS o as PP o o A E 3 1 1 EEO a USE E E A O AAA EA AAA A AAA AAA A 3 MM O E S T T S E A E S A E A E E ane demsaneonens 4 LLA Abh aade p ince TS api oi ono RU PO on aoi nainn ei onia ik opio o aninion 4 LLES Whee a adice o ena o e N A cana ad ca ncuusdes adh seca ounce onecaneatubagnapndaan cues 4 LLA dicivicial patient ractors that can altect Use Oi tie prod a ea ei el 4 Aaa e O O E EUA 4 La na y A N EAEAN A AAE laa ncn sand sebagai anaemia AA ENE T A EA A AE 4 PA MU ETO i o A A lis E E A E E 5 122 Vet A E E A E A AAA A A 5 eA E e tig cates O N O O AN A EE A N ea A A ONE N E EN 5 12A Sensor Or AA o E OO Er o be O EE A aE a aa 6 4 A apse E E E A E E vce ncn O EN E E E A E A E A E E y pene onEanaR 7 1 3 Labels atid DOS ar AA A R 7 E A AAA arrange ete ANCOR TCE CO O A OO PRO Ter rare Teeny ETON O II Teme ae 7 a E ld AAA eee ee ee A A A 8 o e A Ir E E A T 8 La E a A a T E P A A T AO A E ETS 8 Be etter Ag O ARE EANO AEEA EN NA EEE NEE EnaA 8 e o tags e etapa tae rea outcast E o 8 L37 Label Meare to tie metuod tor chato noe battery PA a A VAE NENEN AESA TAU NEENA EEOSE SEN ENEE Na 8 Lio POCERO da rr Tree Tener Ter eer ter rn etry E Tr rer meee ee A ser errr erent E erry errr E EEEN 8 BD MN ee GN ath PI E Oo eh a iat seats tem O O SEO 0 8 1 3 10 LATO MATIOM OA protechon ACA SE motes
19. L FVC repeatable when the difference between the two furthest apart FVC values is lt 150mL 2 11 Performing oximetry A WARNING While performing tests unplug the charger from spirolab A WARNING Check that the oximetry function is available on the device you are using as it is optional on several models A WARNING The description of the following sensor serves solely as an example All the sensors described in section 1 2 4 can be used with the spirolab device MIR does not recommend any particular sensor the decision is left to the doctor s discretion During oximetry tests the spirolab device cannot be turned off To turn it off you have to interrupt an on going test This system prevents unwanted interruptions that might compromise the reliability of data Page 24 of 34 I MIR INTERNATIONAL RESEARCH Spirolab To take a non invasive reading of oxygen saturation SpOz and pulse rate use the reusable finger sensor This sensor is recommended for patients weighing over 20 Kg and with limited mobility or who remain still during tests for tests carried out with the patient walking other types of sensors that are less affected by movements of the hands are recommended To perform an oximetry test proceed as follows Connect the sensor to the device insert the connector with the arrow facing up Choose a site with a good blood flow that is suitable for the sensor Insert the finger all the way into the sensor Make sure
20. NTRODUCTION 1 1 Intended use The spirolab spirometer oximeter is intended for use by qualified medical personnel or by patients under the supervision of a doctor The device has been designed to test lung function and can be used e for spirometry tests on patients of any age excluding babies and infants e for oximetry tests on patients of any age It may be used in any environment except for transporting the patient outside a hospital Page 3of 34 MEDICAL INTERNATIONAL RESEARCH 1 1 1 User type Spirolab The spirolab spirometer oximeter provides information about a series of parameters relating to human respiratory function Use of the device is usually prescribed by a doctor who is responsible for analysing and checking the results and the data gathered during the test period 1 1 2 Ability and experience required The technique for using and maintaining the device along with the ability to interpret the results provided calls for a qualified health worker A WARNING MIR will not be held responsible for any harm or damage of any kind caused by mistakes made by users failing to heed the warnings in this manual If a spirolab user is a person who is incapable of looking after him or herself the device must be used under the supervision and responsibility of the person who is legally in charge of that person When the spirolab device is used as an oximeter it is intended for spot checks sleep checks during the night and
21. Port Profile protocol The following are required for such a connection to be made e Spirolab must have a Bluetooth feature this feature is optional on some models e The Bluetooth setting must be set to ON If these conditions ate met you can search for enabled devices from the master device Once spirolab has been identified you will be prompted to enter your SAURE tlh La PIN this information is found in the service menu in the Device del Info section as shown to the right Serial Number A23 J 02154 Firmware version 1 0 Spirometry Enter the value displayed and continue with the so called pairing Graphic release 5 activity i e pairing the spirolab device and the mater device Oximetr y Bluetooth release 35 Bluetooth PIN 10218 Bluetooth Address 0026 33 00 27 ea Riference Delete results O D a ae w o 5 Oximeter release d SAVE EXIT At this point spirolab can use the connection via SPP Serial Port Profile protocol For details on using the protocol please contact the manufacturer Similarly spirolab can be connected to a PC on which you have installed winspiroPRO Once connected as described above winspiroPRO becomes an interactive panel to control spirolab and hence perform wireless online spirometry and oximetry tests that will be stored directly within the software 3 2 Connecting with a PC via USB port A WARNING Before connec
22. able test but the variation of the two highest FEV1 values is greater than 200 mL F no acceptable test 2nd case POST bronchodilator test A two acceptable tests the variation of the two highest FEV1 values is less than or equal to 100 mL B two acceptable tests the variation of the two highest FEV1 values is between 100 and 200 mL C two acceptable tests the variation of the two highest FEV1 values is greater than 200 mL D one acceptable test F no acceptable test Acceptable means a good start and satisfactory exhalation in duration and flow To facilitate understanding where much information is available regarding the same test the spirolab device will only display the most significant data Vext and PEFT ERROR If the extrapolated volume Vext is greater than 500 mL or greater than 5 of the FVC or when the PEFT Peak Tidal Expiratory Flow is more than 300 ms FET Error If the FET is lower than the threshold setting FLOW ERROR If the last point on the F V curve is more than 200 mL s this means that exhalation has not been completed For each of the cases described the following message is displayed EXHALE ALL THE AIR Between one test and the next the spirolab device evaluates the repeatability of the following parameters PEF repeatable when the difference between the two furthest apart PEF values is lt 10 FEV1 repeatable when the difference between the two furthest apart FEV1 values is lt 150m
23. aken into account in accordance with the reference standard Once the desired ethnic group has been selected the device completes defining the patient parameters and returns automatically to the main screen 2 6 2 Editing patient data ARCHIVE In the main screen you can access the data present in the device sseleu aE A B DATE You can choose to search by m FVC O POST m VC O Mvv OXY e ID e Surname alele le Ta e Date of birth QIWIEJR THY U ofP 1 2 3 e Test date All Ais D FG H J K a 445476 lt gt ZEXEcETvEispginiuol amp 748499 Or select the type of test EJ gz Tola e FVC e POST e VC e OXY Page 19 oF 34 IS MIR MEDICAL INTERNATIONAL RESEARCH Spirolab Each option selected will bring up a box in which you can enter the search data 2 7 2 Viewing archived data The archive displays the list of patients starting with the most recent 4 4 4 y 4 Select patient from the archive and choose a function 02 09 2014 12 22 Ver1 0 Select the patient required by tapping the line which becomes i EN El de pm T orange and choose one of the enabled functions listed at the ales e ae A GS S bottom of the screen aoe a eee PA IM R The enabled icons are coloured while the grey ones are disabled e To quit the archive use the icon sser EJES O E wo E L E ASAVE ExIT A j L FVC EE Vc EE MVV A D Martini Age40 180cm 75 kg 02 09 2014 Parameter Predicted PREPRES1
24. at have been returned to our authorised service centres For further information about service centres please contact your local distributor or the manufacturer The customer is responsible for the costs incurred for shipping customs and the delivery of goods Every product or component part thereof sent for repair must be accompanied by a clear and detailed explanation of the fault If the product or component part thereof is to be sent to the manufacturer this must be authorised in writing or by phone beforehand by the manufacturer MIR Medical International Research reserves the right to replace the product or make any changes to it that the company deems necessaty Page 32 of 34 AN MIR APPENDIX 3 INFORMATION ABOUT THE CORRECT ENVIRONMENT RF emissions CISPR 11 RF emissions Class B CISPR 11 IEC 61000 3 2 Fluctuations intermittent Spirolab USE OF DEVICE IN AN ELECTROMAGNETIC Manufacturer s recommendations and declarations electromagnetic emissions The SPIROLAB device can be used in the following electromagnetic environments The SPIROLAB customer or end user must ensure that the device is used in such an environment Conformity Electromagnetic environment guide SPIROLAB uses RF energy for internal functions only Its RF emissions are therefore very low and are too weak to cause interference with nearby electronic Group 1 devices SPIROLAB is suitable for use in any environment including the home and t
25. ated version of the software is available if this is the case download the software then up date the device with the latest software winspiroPRO version For further information consult the online winspiroPRO User Manual Al The turbine may be dirty Clean the turbine as described in section 4 1 if necessary replace the turbine with a new one The device turns itself off then reboots while being used On completion of spirometry tests the A The test was performed in the Repeat the test following the instructions shown on readings are not credible wrong manner the screen On completion of a Personalised parameter settings Check the heading parameter settings in the spirometer test some in the service menu Spirometry Parameters section of the service parameters are not menu as described in section 2 5 displayed A The sensor is wrongly Reposition the oximeter sensor During an oximeter test the readings displayed are irregular positioned or the patient s perfusion is poor The patient moved For accurate results the patient must not make any intermittent or wrong sudden movements E The brightness level of the None The display is not very display automatically dims 5 bright during tests minutes after a test starts This function extends battery life Problems with charging Defective The battery pack is damaged or Contact technical services the battery pack battery wrongly positioned Unforeseen memory Error i
26. blems for the patient unsuitable materials might cause the device to malfunction and compromise the accuracy of readings It is the responsibility of the user to provide suitable mouthpieces These items generally have a standard 30 mm external diameter and are commonly used by health workers They are widely available Page Sof 34 MEDICAL INTERNATIONAL RESEARCH Spirolab 1 2 4 Sensor for oximetry In addition to the sensor code number 919024 supplied with the device the following specific sensors can also be used for different types of patients BCI 1300 Single use sensor for adults BCI 3026 Reusable neonatal wrap sensor BCI 3043 Reusable universal Y sensor BCI 3078 Reusable paediatric ear sensor BCI 3178 Reusable paediatric finger sensor BCI 3444 Reusable finger sensor for adults Comfort Clip BCI 3044 Reusable finger sensor for adults These sensors require the use of an extension cable for connection with the spirolab device Two lengths of extension cable are available item code 919200 length 1 5 m Prolonged use of a sensor or the patient s condition may mean that the location of the sensor has to be changed periodically Change the position of sensors every 4 hours Moreover check the condition of the skin and blood flow and ensure the sensor is properly aligned A WARNING The incorrect use of a sensor or sensor cable and the use of a faulty sensor or sensor cable may compromise the accuracy of readings a
27. d calibration just a periodical clean The disposable turbine is inspected before it is sealed in the package and hence does not need calibration If however if you want to carry out a calibration bear the following in mind Calibration can be carried out on reusable and disposable turbines Calibration takes place based on the FVC expiratory and FIVC inspiratory values measured during a test performed with a calibrated syringe To access the calibration setting select the service menu item Calibration the first screen Last values allows you to check current percentages applied by the device By choosing New calibration you can calculate new conversion factors Make a test using the syringe calibration Make the following acts in the same sequence SETTINGS 02 09 2014 12 22 Ver1 0 m ESSE New calibration Syringe value Factory values Device urana alan E Spirometry 300 05 03 2015 17 03 e Make an inspiration manoeuvre e Make an expiration manoeuvre oximetry e Make an inspiration manoeuvre once again ae Expiratory calibration 0 Inspiratory calibration 0 Delete results On the display it is shown the graphic of the test lA Then tap seen If calibration correction is lt 10 then the values are shows as in the WHET ERIS eee Nee a Lasivalos following screen Lastvalues yring actory values Tap OK to set the new correction values i nan vekne iek If the values are gt 10 then the f
28. e alarms and thresholds set during an oximetry test To check the oximetry sensor is properly connected during testing To check the presence of a signal during the oximetry test To print a test To delete a test ozre gt mz To cancel an operation and return to the previous step 2 5 Service menu To access the menu press the icon Ed To view headings enter the following code using the virtual numeric keypad 122333 In this screen you can also change the brightness of the display by tapping the orange cursor vertically The brightness will change in real time The service menu will display the following heading sequence Device Spirometry Calibration e Oximetry e References e Delete archive Tap the desired heading to select it Device The section is divided into e General e Date and time eo Info o Printer SETTINGS 02 09 2014 12 22 Ver1 0 DateandTime info Pater Select the desired settings by tapping the white box the selection is highlighted by an orange box For the brightness of the display move the orange cursor vertically until the desired brightness Spirometry To set the correct date and time tap the box to bring up the cursor Calibration use the numeric keypad on the lower right to set the correct value The Info section displays the hardware and software versions of the device s most significant components in addition to the serial number Delete results In
29. e can be up dated Up dates can be downloaded on registration from www spirometry com For further information about downloading up dates refer to the winspiroPro manual 4 MAINTENANCE Spirolab devices need little maintenance You should periodically e Clean and check reusable turbines e Replacement disposable turbines at each test e Clean the oximetry sensor for reusable sensors e Replace the adhesive tape on the wrap type oximetry sensor e Recharge the internal battery pack All the maintenance operations described in the User Manual must be carried out with great care Failure to follow these instructions may lead to incorrect readings or the incorrect interpretation of readings that have been taken All modifications adjustments repairs and reconfigurations must be performed by the manufacturer or by personnel authorised by the manufacturer In the event of problems do not attempt to make repairs The setting of configurable parameters must be performed by qualified staff In no case does the incorrect setting of the device place a patient at risk 4 1 Cleaning and checking reusable turbines The volume and flow turbine sensors usable with spirolab are of two types disposable and reusable These guarantee great accuracy and have the added benefit of not needing to be periodically calibrated A simple clean before every use will ensure that the turbine keeps working as it should only for reusable turbines For disposab
30. eral metres must be obsetved if there are other devices in operation in the same area Examples of such devices include TVs radios domestic appliances mobile phones cordless phones etc The device may provide inaccurate readings in the presence of strong electromagnetic sources such as electrosurgical scalpels or medical devices such as CT equipment Do not use the device in the presence of MRI equipment that can generate an induced current in the oximetry sensor and harm the patient The use of accessories and cables other than those specified by the manufacturer may result in increased emissions or decreased device immunity The spirolab device should not be used close to or stacked with other equipment if it must be used close to or stacked with other equipment spirolab should be observed to verify normal operation in the configuration in which it will be used If the device is used in conjunction with other items of equipment only equipment that complies with current safety regulations can be used so as meet the safety standards laid down by IEC EN 6060160601 1 consequently the PC or printer to which spirolab is connected should comply with IEC EN 60601 1 As tegards the disposal of spirolab devices accessories plastic consumables mouthpieces removable components and items that are subject to ageing e g the battery pack only use suitable containers or better send the materials to the device retailer or an approved disposal cent
31. ers oximetric parameters optional The device can be connected to a PC via a micro USB port Spirolab performs FVC VC amp IVC and MVV tests and the ventilatory profile as well as an acceptability quality control and reproducibility index of the spirometry test carried out by the patient The automatic interpretation function uses 11 levels as per ATS American Thoracic Society classification Every single test can be repeated The best functional parameters will always be available for fast re reading The normality values theoretic can be selected from those available For instance in European Union countries doctors generally use the values recommended by the ERS European Respiratory Society Oximetry function The oximetry sensor features two light emitting diodes LED one emits visible red light and the other infra red Both bands of light pass through the finger to reach a light detector During the passage through the finger some of the light is absorbed by the blood and Page 10 of 34 ANN MIR soft tissue depending on the concentration of haemoglobin The amount of each light frequency absorbed depends on how oxygenated the blood 1s inside the tissue This operating principle ensures accurate and reproducible readings without the need to constantly calibrate the device The oximetry sensor can be disinfected with Isopropyl alcohol Spirolab 1 5 Technical specifications Below is a complete description of the specificati
32. es and flow rates is performed automatically thanks to an ambient temperature sensor that measures the temperature inside the device and allows the BTPS factor to be calculated If a 3 litre syringe is used for the test and if the spirolab device is perfectly calibrated the FVC syringe value measured will be Spirolab 3 00 FVC x 1 026 BTPS 3 08 L FVC at BTPS If the ambient air temperature is 20 C the FIVC syringe value measured will be 3 00 FIVC x 1 102 BTPS 3 31 L FIVC at BTPS The user must be aware that the volume of the syringe shown was converted to BTPS and the alterations of the results when compared with expected values do not therefore represent an error For example if you perform calibration with the data measures FVC 3 08 L and FIVC 3 31 L at an ambient temperature of 20 C the correction coefficient will be EXPIRATORY 00 INSPIRATORY 00 To repeat this is NOT an error but the logical consequence of what was explained above 2 6 Patient data From the main screen you can e access the patient data management area e create a new patient profile or check for existing patients in the archives e change current patient data 2 6 1 Entering new patient data ADD SElL NEW PATIENT DATA 02 09 2014 12 22 Ver1 0 This screen provides access to all patient data The ID code is not cn _ me required Tap the grey space to access the various fields and make Ll E EEE
33. essories might cause erroneous readings or compromise the correct functioning of the device For this reason the use of such items is not permitted Do not use the product if it has passed its shelf life In normal working conditions this is equal to approximately 10 years The battery charge level is constantly monitored by the device itself The device will display a message warning the user if the battery is flat In the event of any incident arising from use of the device we strongly advise the user to inform his or her doctor who will then complete the procedure laid down by Article 9 of Legislative Decree No 46 1997 implementing EC Directive No 93 42 1 2 1 Risk of cross contamination So as to avoid any risk of cross contamination it is imperative to use a single use mouthpiece for each individual patient The device may be used with two types of turbine sensors a reusable one and a disposable one Reusable turbine sensors must be cleaned before being used on a new patient The use of an anti bacterial viral filter is left to the doctor s discretion The disposable turbine sensor must be replaced for each patient 1 2 2 Turbine Disposable turbine A WARNING If you decide to use the spirometer with a disposable turbine it is important to use a new turbine for each patient Adequate hygiene safety and operational conditions of disposable turbines are only guaranteed if said turbines are preserved in the original
34. fra red light as its operating principle measures volume and flow rate This operating principle ensures accurate reproducible results without needing periodic recalibration The key features of this type of sensor are as follows e Accurate readings even with low air flow rates end of exhalation e Not affected by humidity and gas density e Unbreakable and shock resistant e Inexpensive to replace The turbine volume and flow sensor is available in disposable and reusable versions REUSABLE TURBINE DISPOSABLE TURBINE In order to preserve the characteristics of the turbines it is important to observe the following precautions e For the disposable turbine always replace following patient spirometric tests e For the reusable turbine always disinfect before use on a new patient to ensure the best possible hygiene and safety standards To properly interpret the results of a spirometry test it is essential to compare them with the so called normality values that are calculated using standardised patient data or with personal reference values associated with that specific patient s clinical history An individual patient s clinical history values van vary significantly from normality values that always refer to a healthy subject Spirolab can be connected to a PC or another computerised system The spirometric data from every test is stored in the device and can be transferred to a PC and displayed flow volume curves spirometric paramet
35. harge spark This quick and spontaneous transfer of charge can lead to overheating or melting of circuits in electronic components A latent defect can occur when an element sensitive to ESD is exposed to an ESD event and is partially damaged by it The device can continue to function normally and the damage may not be detected by routine checks but intermittent or persistent damage can occur even after a long time With ESD materials charges go to ground or to another conductive object that the material contacts Dissipative materials allow charges to flow to ground more slowly than with conductive materials of equal size Common plastics and glass can act as insulators An insulator retains charges and these cannot be transferred to ground Both conductors and insulators can be charged with electrostatic charges and discharged Grounding is a very efficient instrument against ESD but only conductors can be connected to ground The fundamental principles of control against ESD are Grounding of all conductors including people Removing insulators and replacing them with ESD safe versions Using ionisers Paying attention to areas that are not ESD safe e g using ESD safe product packaging 1 3 10 Information on protection against ingress of liquids The label bearing the inscription IPX1 indicates the degree of protection against ingress of liquids IPX1 The device is protected against vertically falling drops of water 1 3 11 Symbol for de
36. he archive These therefore can be retrieved from the archive and printed either together or individually Numbers may appear on the main screen next to the spirometry test icons for example Page 20 of 34 IS MIR MEDICAL INTERNATIONAL RESEARCH Spirolab The number inside the red circle represents in this case the FVC tests performed in the current session 2 8 Online mode connected to a PC This function acts like an actual laboratory based real time spirometer connected to a PC Connection to the PC can be performed by USB or by a wireless Bluetooth connection Spirolab becomes an intelligent sensor for measuring volume and flow rate while the PC controls the functions including turning on and off When connected to a laptop spirolab can be used for epidemiological tests in workplaces schools etc In addition to the usual spirometric parameters and F V curves in real time this system can also gather more sophisticated information such as ventilatory profiles and extrapolated volume Vext data The computer software allows the use of more up dated bronchial provocation protocols and can display FEV1 dose and time responses A WARNING When the device is connected to a PC it cannot be remotely operated The settings on the PC are transferred to the device and remain active any other time you use the device remotely For example if you use spirolab connected to the PC and you set a particular turbine disposable or
37. hh mm ss T lt 40BPM Time passed with Pulse rate lt 40 BPM hh mm ss T gt 120BPM Time passed with Pulse rate lt 120 BPM hh mm ss Accuracy of SpO2 Acoustic signalling e Beeps with frequency depending on pulse rate e Sounds in the event of exceeding pre set threshold values of the SpO or pulse rate e Sounds during oximetry if battery low e Sounds in the event of no signal present finger not inserted properly connector not properly attached e Sounds the next time the device is turned on following an interrupted test due to low battery The specifications that apply to oximetry and pulse rate are the same regardless of the sensor used as long as it is one of those mentioned beforehand 1 5 3 Other features The memory can store the data from over 10 000 spirometric tests The exact number has not be established as it depends on the configuration set by the doctor Display 7 inch colour touch screen LCD Display with 800x480 resolution Memory Keypad USB Bluetooth Page 12 of 34 AN MIR Spirolab Frequency range 2402 2480 MHz Output power 0 001 W Bluetooth interface Frequency tolerance 20 ppm Type of antenna permanently attached Antenna gain 0 max dBi Degree of protection against water 5 Pp 5 IPX1 appliance protected against water leaks penetration Safety level in the presence of flammable anaesthetic gases oxygen Appliance not suitable and nitrogen Temperature MIN 40 C MAX 70 C
38. his company may compromise the use of the device by the user NOTE This device has been subjected to tests that confirm it complies with the limits of a class B digital instrument as per section 15 of the FCC Standards These limits have been set to provide appropriate protection against interference when the device is used in the home This device generates uses and can emit radio signals and if not installed or used as per instructions can create interference with radio communications The absence of interference cannot however be guaranteed for all installations If this device causes interference to radio or TV reception that can be determined by turning the device on and off we recommend the user corrects the interference by adopting one of more of the counter measures listed below e Change the angle or position of the antenna e Increase the distance between the device and the appliance receiving the signal e Connect the device to a different power socket than the one used by the appliance receiving the signal e Contact the supplier or radio TV technician for expert advice The symbols defined may be found on the device ID label 13 9 Electrostatic discharge symbol Page 8 of 34 MEDICAL INTERNATIONAL RESEARCH This symbol required by the EN 60601 1 2 International Standard is used near every connector that has been excluded from the electrostatic discharge test A WARNING The contacts of connectors identified with the ESD
39. hose directly connected to the public low voltage power supply that supplies buildings used for domestic purposes Not applicable voltage emissions ITEC 61000 3 3 Manufacturer s recommendations and declarations electromagnetic immunity The SPIROLAB device can be used in the following electromagnetic environments The SPIROLAB customer or end user must ensure that the device is used in such an environment Immunity test Test level Level of Electromagnetic environment guide IEC 60601 conformity Electrostatic Discharge ESD IEC 61000 4 2 High speed data transmission lines IEC 61000 4 4 power surges IEC 61000 4 5 Drops in voltage short interruptions and voltage variations in the power supply feed line IEC 61000 4 11 Frequency of magnetic field 50 60 Hz IEC 61000 4 8 6 kV contact 8 kV air T kV per input output line 1 kV differential mode 2 kV common mode lt 5 UT gt 99 gaps in for 0 5 cycles 40 UT 60 gaps in for 5 cycles 70 UT 30 gaps in for 25 cycles lt gt Yo UT gt 95 gaps in UT for 5 seconds 6 kV contact 8 kV air Not applicable Not applicable Floors should be made of wood cement or ceramic tiles If floors are covered with synthetic materials Relattve Humidity must be at least 30 In the event of an electrostatic discharge occurring during an oximeter test the device will recover its functionali
40. isplay or Bi EAC a spirometry AAA e dada E A 23 210 4 Wt Stone Ur paa oO ro 23 2 11 Pornoen i MV cc wc dete Ne tra cg ried lpi ee ras esl vob wba dtd uta do date E eon acuta ss 24 211 1 TSC ORS Tor using the sensor on individual adult PASES seeren eese eneas eaaa A NA Ac 26 O E IA SANAA A OS 27 3 1 Ieee a on o PP E REEE EEE E E e 27 De Connecting mitra PC Ha USD pOr E O A A E A A E A A 2 3 3 ss AA asta E oo O AN PS N nn UA EA OAA O E ie 28 3 4 Ue intenna A o A a 28 ect E E E E E E E E E E E E E T 28 4 1 Gleaninrand checking teus able EDINE Sirain N A EEEE RANA AR 28 i Wy ME o o esa tibie iA AAA CN PI A ny rs Orr ren ter nner e 29 4 2 Ao A O UR PI T O AA T OI O E TT 29 4 3 a a E A E E E E E E 0 O A 29 4 4 Kocka no EE Ae ic E E E E E EE S EE E N EE EE A EE oi 29 ww TROUBLE SHOTS EAN SOLUTION Soap 30 osa I A E E SE 0 e e E ES EA 32 APPENDIX 3 INFORMATION ABOUT THE CORRECT USE OF DEVICE IN AN ELECTROMAGNETIC ENVIRONMENT ereere 33 Page 2of 34 MEDICAL INTERNATIONAL RESEARCH Thank you for choosing a MIR product Spirolab MEDICAL INTERNATIONAL RESEARCH This manual refers to the spirolab generation with serial number as follows A23 0J xxxxx Where A23 0J is the root XXXxXx Is a sequential number The accessories supplied are ticked on the cover of the New spirolab device equipment supplied with the device Before using your spirolab e Carefully read the user manual the labels and all the information supplied with the device
41. lades move correctly the device will emit repeated beeps that vary in frequency with the flow of the air passing through e If no beeps are emitted during this movement clean the turbine 4 2 Cleaning the oximetry sensor The reusable oximetry sensor must be cleaned at every change of the patient 1 e before applying it to a new patient Clean the sensor with a damp cloth containing water or a delicate soap solution To disinfect the sensor rub it with isopropyl alcohol After cleaning allow the sensor to fully dry Do not use abrasive or caustic agents to clean the sensor A WARNING Do not sterilise by means of radiation steam or ethylene oxide Always disconnect the sensor before cleaning or disinfection Spirolab sensors are latex free 43 Replacing wrap sensor adhesive tape The disposable adhesive tape is made with latex free materials e Gently remove and dispose of the adhesive tape from the sensor e The back of the sensor has lines indicating where the tape should go Position the sensor with these pins facing the tape and line up the pins and tape e Press the sensor firmly to insert the pins into the holes in the tape Lift both the sensor and the tape to check that the pins are properly lined up A WARNING Being disposable we recommend using new tape for every patient or as needs must 44 Recharging the battery pack A WARNING To charge the battery pack only use the charger supplied by the manufacturer When
42. lculated based on FEV1 L s VC Slow Expiratory Vital Capacity E EVC Expiratory Vital Capacity L IVC Inspiratory Vital Capacity L IC Inspiratory capacity maximum between EVC and IVC ERV L ERV Expiratory reserve volume L IRV Inspiratory reserve volume L VT Tidal Volume L VE Minute ventilation at rest L min Rf Respiratory frequency Breaths min tI Average inspiratory time at rest S tE Average exhalation time at rest S VT tl Mean inspiratory flow at rest L min t tTOT tI tI tE MVV Maximum voluntary ventilation L min BLA Estimated Lung Age years Page 11 of 34 AN MIR Spirolab best values 1 5 2 Oximeter specifications Definitions Drop in SpO2 gt 4 in a 8 40 sec period limited and subsequent rise gt 2 inside an overall period of 150 sec Rise in Pulse gt 10 BPM in a 8 40 sec limited period and subsequent drop gt 8 BPM inside an overall period of 150 sec Desaturation event Pulse variation event Oximetry test parameters SPO2 min Minimum SPO2 during the test 0 SPO2 max Maximum SPO2 during the test 0 BPM min Minimum BPM during the test BPM BPM max Maximum BPM during the test BPM Median SPO2 Median SPO2 0 Median BPM Median BPM BPM T Total Duration of the test hh mm ss Analysis T Total measuring time duration of test excluding zeroes hh mm ss T lt 90 Time with SpO2 less than 90 hh mm ss T lt 89 Time with SpO2 less than 89 hh mm ss ES Time with SpO2 less than 5 of the mean value
43. le turbines cleaning is not necessary as they are supplied clean and packaged in sealed envelopes When you have finished using them they should be discarded A WARNING It is good practice to periodically check that no impurities or foreign bodies such as skin or even worse hairs have deposited inside the turbine Such obstacles could slow or block the turbine blades and compromise the accuracy of readings Before every use perform the test described in section 4 1 1 below that allows you to test the efficiency of the turbine If the result is negative act as follows To clean a reusable turbine remove it from its housing in the MiniFlowmeter by turning it anti clockwise and pulling gently To facilitate removal you can push the bottom of the turbine gently with a finger Soak the turbine in a cold liquid detergent and shake it so as to remove any impurities that have deposited inside leave to soak for the period of time recommended by the detergent manufacturer that is shown in the instructions for use A WARNING To avoid irreparable damage to the turbine do not use alcohol or oil based detergent solutions and do not soak in water ot hot solutions Never place the turbine in an autoclave Do not sterilise the turbine Never clean the turbine under running water or spray with other liquids If no liquid detergents are available clean the turbine with at least clean water MIR recommends the use of Dupont Perasafe that has been te
44. n The data stored in the archive Contact technical services error memoty have been damaged The device will freeze A Press the on button 3 times wait a few seconds and when unforeseen events the device will reset then turn itself on occut A WARNING Before contacting the service centre if possible download the device archive to the PC using the winspiroPRO program This is necessary as the data may be lost during repair activities and also to protect the patient s privacy as neither the manufacturer nor authorised personnel are allowed to see such data Page 30 of 34 AN MI AN MIR MEDICAL INTERNATIONAL RESEARCH Spirolab User manual Via del Maggiolino 125 00155 Roma ITALY EC Declaration of Conformity appendix II excluding para 4 We declare that the following device Type Make Name of Device Class nternational Research conforms to the Essential the Member States This declaration is based nts of Directive 93 42 concerning Me es and its amendments and its transposition in tificate No MED 9826 issued by Cer Rome 01 01 2015 y Paolo Sacco Boschetti President Page JLo 34 MEDICAL INTERNATIONAL RESEARCH GUARANTEE CONDITIONS Spirolab The spirolab device and authorized accessories are guaranteed for a period of e 12 months in the case of professional use doctor hospital etc e 24 months where the product has been purchased by a patient for private use The guaran
45. n a spirometry test performed after administering the patient a bronchodilator The tests subsequently performed on the selected patient show the following parameters e The values for the test performed e The values of the best PRE test performed by the same patient on the same day i e in the same session e The percentage change between PRE and POST values in the column labelled CHG You cannot perform a POST test on a patient if the archive only contains PRE tests carried out on previous days sessions other than the current one If during a POST session you create a new patient or retrieve another patient from the archive the device automatically exits the current POST session 2 10 Displaying and reading spirometry results 75 kg Male 02 09 2014 12 22 Verio PREPRE Pred PRESRERAN D Martini Age40 180cm Once the FVC test has been completed the spirometry results ate displayed The screen shows the Flow Volume graph the parameters selected in the settings relating to the best test among those performed in the session and the percentage ratio compared to theoretical values Scroll through the parameters area to view any other parameters set Parameter Predicted 1 48 Quality EXHALE ALL air in thelungs Interpretation Best values Obstruction AT eece Hormal Spirometry Restriction na AO ee Quality grade D Ripeatability PEF TA IO ta Y poo ES LSAVE EXIT FVC vc MVV OXY
46. nd indeed generate seriously incorrect readings of the patient s condition Check every sensor carefully before use Do not use sensors that appear to be or are damaged If you do not have any more working sensors contact your local distributor who supplied the device Only use MIR sensors that have been specifically designed to work with spirolab The use of other sensors may provide faulty readings Oximetry results may be faulty if the test is performed under very bright conditions If necessary cover the sensor e g with a clean cloth A WARNING Any colouring agent present in the blood e g for performing diagnostic tests such as methylene blue indocyanine green indigo carmine patent blue V PBV can compromise the accuracy of oximetry readings Any condition that restricts the flow of blood e g the use of a cuff to measure blood pressure can compromise the accuracy of SpO2 and pulse rate readings False nails and nail varnish must be removed before using the sensor as they might compromise the accuracy of oximetry readings Significant levels of dysfunctional haemoglobin such as carboxyhemoglobin or methemoglobin affect the accuracy of oxygen readings If two or more oximetry sensors are positioned near each other optical interference may occur Such interference can compromise the accuracy of oxygen readings To eliminate any such interference cover the sensors with an opaque material Dirt or obstructions that bl
47. nstructions for using the sensor on individual adult patients A WARNING The description of the following sensor serves solely as an example Any of the sensors described in 1 2 4 can be used with the spirolab device MIR do not recommend any particular sensor that decision is left to the doctor s discretion To monitor non invasive readings of arterial blood oxygen saturation we recommend the use of wrap type reusable sensors A WARNING The sensors are made from PROTEIN FREE NATURAL LATEX materials The materials used in making the sensors have been subjected to stringent biocompatibility tests A WARNING Use of this sensor is recommended for patients weighing over 30 kg and not recommended for use on patients who display allergic reactions to adhesive tape The sensor is for mono use for individual patients e Choose a suitable site for application on the patient s finger or toe that will allow the light source to line up directly with the detector The preferred sites are the index finger or thumb e Remove any nail polish or false nails e Position the patient s finger in the sensor with the nail face up and place the pad of the finger over the detector An imaginary line through the middle of the sensor should pass through the tip of the finger e Apply the adhesive tape to under part of the finger taking care not to cover the nail e Fold the upper part of the sensor over the finger making sure that the light source
48. ock the red light on the sensor or that block the detector may provide inaccurate readings ot sensor malfunctions Always make sure that the sensor is clean and free of obstructions Never place the sensor in an autoclave Do not sterilise the sensor Before cleaning the sensor disconnect it from the spirolab unit to prevent damage to the sensor and device and to avoid compromising user safety Page Gof 34 MEDICAL INTERNATIONAL RESEARCH 120 The unit Spirolab A WARNING All the maintenance operations described in the User Manual must be carried out with great care Failure to follow these instructions may lead to incorrect readings or the incorrect interpretation of readings that have been taken Do not modify the device without authorisation from the manufacturer All modifications adjustments repairs and reconfigurations must be performed by the manufacturer or by personnel authorised by the manufacturer In the event of problems do not attempt to make repairs The setting of configurable parameters must be performed by qualified staff The incorrect setting of parameters however will not compromise a patient s state of health On request the manufacturer can provide electrical diagrams parts lists descriptions and calibration instructions to assist the technicians with repairs The high frequencies emitted by an electronic device can interfere with the functioning of the device For this reason a minimum distance of sev
49. ollowing message appears on the Spirometry 300 REIS T709 screen Oximetry Sana Expiratory calibration Inspiratory calibration Delete results ki Confirm Calibration The FVC and FIVC values are not accepted This means that the system is unable to correct such a large calibration error In this case check that the spirolab is working properly by fitting a new turbine and or clean the turbine in question To cancel the calibration in use and restore the factory settings select Factory values from the calibration menu fy gs ry Then tap de Page 17 of 34 MEDICAL INTERNATIONAL RESEARCH A WARNING According to the Standardised Lung Function Testing publication of the European Respiratory Society Vol 6 Supplement 16 March 1993 air expelled from the mouth has a temperature of about 33 34 C To convert the volumes and air flow rates to BTPS 37 C conditions they must be increased by a factor of 2 6 The BTPS factor for a temperature of 33 C is 1 026 which is in fact a correction of 2 6 In practice the BTPS factor for expiratory volumes and flow rates is constant and equal to 1 026 The BTPS factor for inspiratory volumes and flow rates depends on ambient temperature as air that is inhaled is at that temperature For instance with an ambient temperature of 20 C with Relative Humidity of 50 the BTPS factor is 1 102 which represents a correction of 10 2 The correction of inspiratory volum
50. ons for the device the turbine volume and flow sensor and the oximetry sensor 1 5 1 Spirometer specifications Parameters measured FVC Best FVC L FEV1 Best FEV1 L PEF Best PEF L s FVC Forced Vital Capacity L FEV1 Volume exhaled in 1st second of the test L FEV1 FVC FEV1 FVC x100 FEV1 VC FEV1 best between EVC and IVC x 100 PEF Peak expiratory flow L s PEF Time Time to achieve 90 of the PEF S FEF 2575 Median flow between 25 and 75 of FVC L s FEF7585 Median flow between 75 and 85 of FVC L s FEF25 Maximum flow at 25 of FVC L s FEF50 Maximum flow at 50 of FVC L s FEF75 Maximum flow at 75 of FVC L s FEVO5 Volume exhaled after 0 5 seconds L FEV05 FVC FEV05 FVC x 100 FEVO75 Volume exhaled after 0 75 seconds L FEV075 FVC FEV075 FVC x 100 Mo FEV2 Volume exhaled in the first 2 seconds of the test L FEV2 FVC FEV2 FVC x 100 FEV3 Volume exhaled in the first 3 seconds of the test L FEV3 FVC FEV3 FVC x 100 FEV6 Volume exhaled in the first 6 seconds of the test L FEV1 FEV6 FEV1 FEV6x100 FEV1 PEF FEV1 PEF empey s index L L s FEV1 FEVO 5 FEV1 FEVO 5 FET Forced exhalation time S EVOL Extrapolated volume mL FIVC Forced Inhalation Vital Capacity L FIV1 Volume inspired in the 1st second L FIV1 FIVC FIV 1 vis PIF Peak inspiratory flow Lis FIF25 Maximum flow at 25 of FIVC L s FIF50 Maximum flow at 50 of FIVC L73 FIF75 Maximum flow at 75 of FIVC L s FEF50 FIF50 FEF50 FIF50 x 100 MVVcal Max voluntary ventilation ca
51. re Local legal requirements in force must be complied with in all cases Failure to comply with the above mentioned regulations will relieve MIR of all responsibility from any direct or indirect claim for damages Use only the battery pack specified in Technical Specifications The device can also be powered using a USB cable connected to a computer thus also allowing online operation Keep the device out of the reach of children and differently able persons 1 3 Labels and symbols 1 3 1 ID label A23 0J 00002 K spirolab T IPX1 Rx ONLY ammi FCC ID TUK MIR045 wil MIR via del Maggiolino 125 CE 00155 Roma Italy 0476 The label shows e Device serial number SN e Product name REF e Antenna symbol for devices that include RF transmitters e Manufacturer s name and address e gt Electrical safety symbol e CE mark as per Council Directive 93 42 CEE e WEEE symbol e FCC Identification code FCC ID e Reference to US FDA regulations Rx Only e Degree of protection against penetration by external agents IPX1 Page Tof 34 MEDICAL INTERNATIONAL RESEARCH 1 3 2 CE mark for medical devices Spirolab CE This product is a Class lla medical device that is certified and in compliance with the requirements of Council Directive 93 42 EEC As per IEC601 1 the product and its component parts are type BF and therefore offer protection against electrical shocks 13 3 Electrical safety symbol 13 4 USB port wa
52. reusable this will remain the default turbine any other time you use the device remotely It is important therefore to be careful when setting the type of turbine 2 9 Performing a spirometry test A WARNING While performing tests unplug the charger from spirolab To correctly perform a spirometry test observe the following instructions to the letter e Slide the turbine fully into position in the MiniFlowmeter then turn it clockwise until it clicks into place e Connect the MiniFlowmeter to spirolab as show in the image on the right e Slide the mouthpiece at least 0 5 cm along the groove on the turbine e Fit the nose clamp over the patient s nostrils to prevent air from escaping e Take the MiniFlowmeter with both hands or alternatively hold it as you would a mobile phone e Introduce the mouthpiece into the mouth behind the teeth making sure that air does not escape from the sides of the mouth A WARNING The proper positioning of the mouthpiece behind the teeth is essential to eliminate any turbulence that might have a negative effect on the test parametets A WARNING We recommend that the patient stays upright during the test and bends forward during exhalation to allow the abdominal muscles to facilitate the expulsion of air The main screen contains the following icons to perform various types of tests ID FVC Spirometry test Wi VC spirometry test hw MVV spirometry test Page 21 of 34 MEDICAL
53. rning label For connecting the device to a PC Only use cables supplied by the manufacturer and observe the IEC 60601 1 safety standards 1 3 5 SpO2 oximetry port warning label SpO2 E This symbol applies to European Directive 2002 96 EEC on Waste Electrical and Electronic Equipment On completion of its useful life this appliance must not be disposed of as urban waste but must be sent to an authorised WEEE waste disposal centre The device can also be sent back to the original supplier free of charge when a new equivalent model is bought Due to the materials used in its manufacture disposal of the device as urban waste could harm the environment and or health There are legal penalties in place for those who fail to observe the legal requirements mentioned here 1 3 6 WEEE label 1 3 7 Label relating to the method for charging the battery pack The symbol is screen printed next to the connector for connecting the battery charger O e i p 8 porate DC IN 12V Only use the charger supplied by the manufacturer Features of the battery charger model AC DC 12W N1EFM 1 3 8 FCC certification label Spirolab complies with section 15 of the FCC standards Operation of the device is subject to the following conditions 1 This device must not cause harmful interference 2 This device can be subjected to all types of interference including those which may cause undesired effects Any modifications made without the express approval of t
54. s reason the power key s symbol is O corresponding to the standby mode 2 2 Saving energy The internal battery pack charge is shown in the upper right hand corner of the display by the symbol If the battery symbol is all green then the battery pack is charged A WARNING To charge the battery pack only use the charger supplied by the manufacturer 2 3 Main screen The device s features can be accessed from the main screen a ab ld ee eale The following section details the features of each icon 02 09 2014 12 22 Verio EJ ADD SEl Turbine Reusable BTPS 1 082 Predicted in use File ERSIKNUDSON Free Memory OBO Ges MODIFY e x lt o gt ma gt 8 pi vv 2 2 4 Symbols and icons The following table shows the icons displayed on the various screens and what they mean _ ua a To access initial settings service menu To enter new patient data D To edit patient data To rerun an archived patient test To access file containing tests performed Fi To save the settings and return to the main screen Es To view the last spirometry session for the current patient Y To view the last oximetry session for the current patient Page Mof 34 aS MIR MEDICAL INTERNATIONAL RESEARCH Spirolab Me To test oximetry D To test FVC spirometry W To test VC spirometry w To test MVV spirometry To run a bronchodilator test POST To check th
55. s these may compromise results A WARNING When the spirolab device is used as an oximeter it has a limited alarm system and for this reason the SpO2 and pulse rate shown on the display need to be checked frequently 1 2 Important safety warnings Spirolab devices have been examined by an independent laboratory that has certified their conformity with EN 60601 1 safety standards and guaranteed that their electromagnetic compatibility is within the limits laid out in EN 60601 1 2 Page 4of 34 MEDICAL INTERNATIONAL RESEARCH Spirolab devices are subject to continuous checks during production and therefore comply with the safety and quality standards laid down in Council Directive 93 42 EEC for Medical Devices Once the device has been removed from its packaging examine it carefully to make sure there are no signs of damage In the event of any damage do not use the device but return it immediately to the manufacturer for possible replacement A WARNING Spirolab Patient safety and device performance are only guaranteed if warnings and current safety standards are complied with The manufacturer declines all responsibility for harm or damage caused by failure to follow the instructions of use The product must be used as described in the User Manual especially as regards Intended Use and only original accessories as specified by the manufacturer are to be used The use or non original turbine sensors oximetry sensors or other acc
56. sted on all MIR sensors Rinse the turbine by immersing it in clean water not hot Shake off any excess water off the turbine Leave the sensor to dry by placing it in an upright position on a dry surface Before re fitting the turbine check that it is working properly It is good practice to visually check that the blades are moving freely Place the turbine on its side and slowly move the blades left and right They should rotate freely If this is not the case the accuracy of readings is no longer guaranteed and the turbine will have to be replaced Page 28 of 34 MEDICAL INTERNATIONAL RESEARCH Spirolab On completion of cleaning replace the turbine in its housing making sure that it is in the right position as shown by the closed padlock symbol on the MiniFlowmeter To insert the turbine correctly push it fully in and turn it clockwise until it clicks into place inside the plastic housing To double check that the turbine is working correctly repeat the checks described in 4 1 1 if the turbine is still problematic replace it with another A WARNING If disposable turbines are being used do not perform any cleaning operations but replace the turbine for a new patient 4 1 1 Checking correct turbine function e Turn the spirolab on and act as if you wanted to perform a spirometry test e Take the MiniFlowmeter in one hand and move it slowly from right to left and vice versa so that air passes through the turbine e If the b
57. t with the graphic trend of the SpO2 and BPM always on the left and the numerical values of the various parameters on the right E Spo2 Mean 96 4 Mnimum 96 Maximum 97 e Mean 74 0 Minimum 56 Maximum 82 AS inutes You may cancel the test by using the icon on the lower right ae OU i Kee If you want to perform a new test on the selected patient from this 190 au sai 7 150 nal s Time 0 screen you can use the icon for the test to be performed a message w Teo 00 00 00 is displayed to confirm whether or not you wish to perform a new 90 n oein test on the selected patient Tap YES to confirm or NO to go sal Tone o omo back 30 gt 3 4 E minutes T gt 120BPM 0 00 00 00 ack ma m ea i OL D wiwo w l If the patient has performed several spirometry or oximetry tests the initial list indicates in brackets next to the type of test the number of tests saved a To view tests other than the first tap the icons a for spirometry or Y for oxymetty 2 7 3 Displaying the last test session During test sessions the spirometer automatically saves up to 8 FVC tests From the main screen using the icon e om in the case of spirometry tests e om in the case of oximetry tests you can view the best three session tests where PRE1 is the best At the end of the session when you enter a new subject or switch to a POST phase the 3 best tests of the previous session are automatically saved in t
58. ted correctly icon transforms into X and the icon A appears alongside it At the same time the spirolab will beep if set to do so in the service menu If the sensor has been inserted but the finger is not positioned correctly the icon transforms into mK and the icon A appears alongside it At the same time the spirolab will beep if set to do so in the service menu By tapping the M icon you can pause the alarm for a few minutes If the alert situation persists after a few minutes the beeping resumes If the signal is received properly by the sensor after a few seconds the device will begin to beep and display readings on the screen Alarms can be set for oximetry tests as explained in section 2 5 Page 25 of 34 MEDICAL INTERNATIONAL RESEARCH If during a test the SpO2 or BPM rate goes above or below its threshold the spirolab emits a beep if set to do so in the service menu for as long as this anomaly continues Spirolab A WARNING Tests are stored with the code of the last patient displayed if this relates to a patient previously inserted before carrying out the test retrieve a test carried out previously on the subject in question and proceed as described in paragraph 2 7 2 During oximetry tests the battery level is displayed This lets you estimate how long the device will run for given the condition in which it is operating display at maximum or energy saving mode To end a test tap 2 11 1 I
59. tee takes effect from the date of purchase shown on the invoice or other document The guarantee period starts from the date of sale that must be confirmed by an invoice or sales receipt The product must be checked at the time of purchase or upon receipt and the manufacturer must be informed immediately of any complaints The guarantee covers repair or at the manufacturer s discretion replacement of the product or defective components without any cost for labour or spare parts The batteries and components subject to wear and tear including the reusable turbine are excluded from the terms of this guarantee At the manufacturer s discretion the guarantee does not apply to the following cases e Uses that are incorrect improper or do not conform to the technical or safety standards in force in the country where the product is being used e Use of the product for purposes that differ from those in the Instructions for Use or failure to observe such instructions e Repair adaptation modification or manhandling by personnel who have not been authorised by the manufacturer e Damage caused by a lack of or by incorrect maintenance e Damage caused by physical or abnormal electrical stress e Damage caused by faults in the electrical systems or in items of equipment to which the device has been connected e Series number modified erased removed or obliterated The repairs and replacements mentioned in the guarantee take place on goods th
60. that the under part of the finger completely covers the detector If you cannot position the finger properly use a different finger Position the sensor so that the cable runs over the back of the hand This ensures that the light source stays on the same side as the nails while the detector remains under the finger To enter the oximetry area press o on the main screen If the following message appears at start up OXIMETER NOT PRESENT this means that your device does not have this function A WARNING If before starting a test the power supply is low the following message will appear Low battery a In this case press to exit the test otherwise the device will start the test a few seconds later If a test is interrupted for some unexpected reason the next time the device is turned on the following message will appear WARNING the last oximetry test was improperly interrupted At the same time the device will beep intermittently for 4 seconds The spirolab will then display the main screen A WARNING To avoid compromising the reliability of readings and to protect the sensor do not twist the sensor cable without reason or use excessive force when using connecting disconnecting or putting away the oximeter sensor The first few seconds of a test are used for finding the strongest signal once this has been found the timer resets itself and the spirolab starts saving data If the sensor 1s not inser
61. the maximum power output of the radio communication devices Specified 150 kHz 80 MHz 80 MHz 800 800 MHz 2 5 GHz maximum power Z output of the transmitter For the specified maximum power output of a transmitter not included above the recommended separation distance d in metres m can be calculated using the equation that applies to transmitter frequency where P is the transmitter s nominal maximum power output in Watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the separation distance calculated for the highest frequency rage is applied NOTE 2 These guidelines may not apply for all situations The propagation of electromagnetism is influenced by absorption and reflection caused by structures objects and persons Page Sof 34
62. ting the spirolab to the PC via USB you need to install the winspiroPro program that allows you interface with the device Before starting to use the following procedure it is important to know the version of the operating system on the PC you will be connecting with click on system in the Control Panel to see information the installed OS If winspiroPRO has already been installed the following actions are not necessary To make the connection insert the micro USB connector supplied with the spirolab into the USB port on the PC When you first connect your PC depending on the operating system version in use will automatically install the Microsoft certified driver For more support at this stage refer to the WinspiroPRO software manual Page 27 of 34 MEDICAL INTERNATIONAL RESEARCH 3 3 Printing data Spirolab Spirolab enables you to print both the last test performed and those stored in the archive a z v To print the last test performed retrieve the test using the icon am for spirometry or o for oximetry When you have viewed the test press the icon eam To print a test carried out in the past and stored in the archive perform a search as described in section 2 7 1 once displayed tap The system prints the information selected in the Spirometry Results settings 3 4 Up dating internal software When the device is connected to a PC via the USB port the spirolab internal softwar
63. ty within 30 seconds in accordance with ISO 9919 The main type of power supply must be that present in commercial or hospital settings The main type of power supply must be that present in commercial or hospital settings The magnetic field values must correspond with those present in a commercial or hospital setting NOTE UT is the mains voltage before the application of the test voltage Page 33 of 34 AN MIR The SPIROLAB customer or end user must ensure that the device is used in such an environment RF and mobile communication items of equipment must not be used any closer the separation distance recommended by SPIROLAB including cables as calculated using the equation applicable to the frequency of the transmitter Spirolab Recommended separation distance d 3 5 VP 2 d 3 5 VP 80 MHz at 800 GHz 3 RF conduit 3 Vrms d Z_ VP 800 MHz at 2 5 GHz E IEC 61000 4 150 kHz to 80 6 MHz Where P is the maximum nominal distance of the transmitter in Watts W according to the transmitter manufacturer and d is the recommended separation distance in metres m RF radiated 3V m The intensity of the fixed RF transmitters as determined by an electromagnetic scan of the site could be lower than the level of conformity IEC 61000 4 80 MHz to 2 5 in each frequency interval b 3 GHz Interference near the device may be detected from devices marked with the following symbol Ko NOTE 1 at 80 MHz and
64. vices that include RF transmitters Kd The symbol is applied in accordance with standard IEC EN 60601 1 2 2007 section 5 1 1 for products that include RF transmitters AR Where applied the symbol refers the user to this manual for the correct use of the device Page 9 of 34 1 3 12 Symbol for reading the operating instructions MEDICAL INTERNATIONAL RESEARCH 1 4 Product description Spirolab Spirolab is a portable spirometer that can also features a pulse oximeter feature optional The device can operate completely autonomously or can be connected to a personal computer or printer by means of USB or Bluetooth connections The device is intended for measuring respiratory parameters and monitoring oxygen saturation and pulse rate The device carries out a control test on the quality of the readings taken and can save the results of about 10 000 spirometric tests or a maximum of 900 hours of oximetry data Spirolab is intended for use by medical specialists and it provides them with a powerful but compact tool that can process about 30 functional parameters The device also provides a pharmacodynamic response i e the comparison of spirometric data measured before and after PRE POST administration of a drug for bronchial provocation or bronchodilation The POST data measured after administering the drug is compared with the PRE data obtained before administration A turbine inside the device that uses the interruption of in
65. y is 30 breaths minute The test ends automatically after 12 seconds Page 22 of 34 IS MIR MEDICAL INTERN ATIONAL RESEARCH Spirolab A WARNING To test the service menu test check that the parameter relating to said test is enabled in Set parameters otherwise the icon will be disabled A WARNING It is important to remember to change the disposable mouthpiece and the disposable turbine at the end of a patient s test session 2 94 Running POST tests after the administration of a drug A WARNING To perform a POST test the patient must have performed at least one PRE FVC test on the same day i e in the same session you cannot perform POST tests on PRE VC or MVV tests conversely you can perform POST VC or MVV tests provided at least one PRE FVC test has been performed and archived on the same day To perform 2 POST test proceed AS follows so cae perform POST BD test 02 09 2014 12 22 Verio C3 1D Name Birth date cm kg Gender 12587 D Martini 05 05 1985 178 80 Mal J A FVC 2 VC 1 MVV ea l RESTRICTION GAL Tap on the main screen The screen on the right shows the list of all the patients who have performed a PRE test on the same day Select the patient required and choose one of the features enabled below The user is prompted to confirm the move to POST mode tap YES to catty out the test in POST mode or tap NO to go back a Tio a ee SAVEJEXIT FVC DATA OXY By POST test we mea

Spirolab User manual Rev. 1.3 Date issued 12.03

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