Spirolab III User’s Manual Rev.
Thank you for choosing a product from MIR Medical International Research The original packaging contains one of the following spirometers, complete with its standard accessories: PRODUCT without oximetry option MiniFlowmeter sensor SpirolabIII User’s Manual USB connection cable Connection cable RS 232, 9 pin for PC 1 power supply (110V) CD winspiroPRO Roll of thermal paper 1 nose clip 2 paper mouthpieces 2 disposable turbine sensors 1 reusable turbine sensor 1 spare fuse (internal) 2A 1 spare fuse (intern
Manufacturer’s address: MIR srl: Via Del Maggiolino, 125 00155 Roma, Italy Tel ++ 39 0622754777 Fax ++ 39 0622754785 e-mail: mir@spirometry.
INDEX INTRODUCTION................................................................................................................................................................. 6 1 GENERAL INFORMATION ......................................................................................................................................... 6 1.1 Intended use .......................................................................................................................................................
Example of oximetry test report .................................................................................................................................... 43 Information for correct use in an electromagnetic environment ....................................................................................
INTRODUCTION The spirometers series MIR009 are sold with the SpirolabIII trademark. SpirolabIII is available with two different displays: • • Colour LCD display B/W LCD display Unless otherwise specified, from this point onwards the term SpirolabIII is used to refer to both models. 1 GENERAL INFORMATION 1.1 INTENDED USE 1.1.1 User Category SpirolabIII, spirometer + oximeter calculates a series of parameters relating to human respiratory function.
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# 6 ' • • • • • • • • # ' ) ' ' ' % # ' ' ' * ? ' 17 % 9- : % ' ' & # ) ) ! 0 ' @ ' ' ' ) ' # ' # % ' ! % ' " ' ' ' ' ' & ? 4 < & ' ' ' ' % ' 0 ) A 0 %6 ' * ' & 1.2.1 Danger of cross-contamination Two different types of turbine sensors can be used with the device, one is reusable and one is single-patient disposable. A mouthpiece is required in order to connect a subject to the spirometer.
Do not allow dust or foreign bodies to enter the turbine sensor, in order to avoid incorrect functioning and possible damage. The presence of any impurities such as hair, sputum, threads etc. within the body of the turbine sensor may seriously compromise the accuracy of the measurements. To avoid environmental contamination by cleaning waste products, the user must adhere to all relevant regulations. 1.2.
SpirolabIII ! * 0 9 ) 1.3 : # # > PROBLEMS AND UNFORSEEN ERRORS In case of a problem, one of a series of messages will appear on the screen together with an acoustic signal to indicate the nature of the problem. Operation of the device beyond its declared life could provoke a loss of data in the memory of the device (SRAM memory).
Warning symbol for the serial port. To connect other devices such as PC or printer to the RS 232 serial port use only the serial cable supplied by the manufacturer and observe the safety regulations of EN 60601-1-1 Symbol laid down in the 2002/96/EEC requirements regarding the disposal of electrical and electronic devices, (WEEE). At the end of its useful life this device must not be thrown away with normal domestic waste, instead it must be delivered to a WEEE authorised collection centre.
1.
*PEF FVC FEV1 FEV1% FEV1/VC% PEF FEF2575 FEF25 FEF50 FEF75 FEV6 FEV6% FET VEXT FIVC FIV1 FIV1% PIF MVVcal VC IVC IC ERV TV VE RR tI tE TV/tI tI/Ttot MVV Best PEF Forced Vital Capacity st Volume expired in the 1 second of the test FEV1/FVC x 100 FEV1/VC x 100 Peak expiratory flow Average flow between 25% and 75% of the FVC Forced Expiratory Flow at 25% of FVC Forced Expiratory Flow at 50% of FVC Forced Expiratory Flow at 75% of FVC Volume expired in the initial 6 seconds of the test FEV1/FEV6 x 100 Forced e
T< 40 BPM T> 120 BPM N° Events < 40 BPM N° Events > 120 BPM Tot. Desat.
Parameters required for walk test: SYMBOL Dyspnea Borg Baseline Dyspnea Borg End Fatigue Borg Baseline Fatigue Borg End Walked DESCRIPTION Grade of dyspnea before walking Grade of dyspnea after walking Level of fatigue before walking Level of fatigue after walking Distance covered during walking \ \ \ \ m Units Parameters measured with SpO2 Analysis: SYMBOL SpO2 Baseline SpO2 Min SpO2 Max SpO2 Mean BPM Baseline BPM Min BPM Max BPM Mean Recording time T < 90% T < 89% T < 88% T < 87% N° Events SpO2 < 89%
Each test can be repeated as required. The best parameters are always available for quick viewing or printing. The normal (predicted) values can be selected from five different authors. In general, within the European Union the ERS (European Respiratory Society) predicted values are used. The device also calculates the response to drug administration, i.e.
2.1 ILLUSTRATION OF SPIROLABIII Display Thermal paper container Keyboard Miniflowmeter sensor Flow sensor compartment Oximeter sensor 2.
Specifies female sex Specifies male sex Confirm last operation. This key is the ENTER key Move cursor 2.3 CHARGING THE BATTERY Make sure that the electrical information on the label of the charging unit corresponds to that of the power source. 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.
2.5.2 Loading the thermal paper Open the lid of the thermal paper compartment and remove it from the device; remove the paper roll holder. Insert the new roll of paper onto the paper roll holder. ' 6 Guide to the correct positioning of the paper roll holder Push the paper into the slot located under the traction reel (black rubber reel). A sensor (as indicated in the image) detects the paper and automatically advances it. This image shows the position of the paper in relation to the traction reel.
Before carrying out a spirometry test, verify that there are no foreign bodies present inside the flow sensor. Connect the connection cable to the Miniflowmeter until hearing the ‘click’ which indicates that it has been correctly inserted. Connect the other end to the SpirolabIII as shown in the image; again the ‘click’ will indicate the correct insertion. Make sure that a new disposable mouthpiece has been correctly inserted in the turbine (mouthpiece holder).
CONFIGURATION MENU • • • • • Delete data in memory Print last calibration Turbine calibration Printout header text Change DATE/TIME Choose operating language Choose predicted values Setup parameters/printout Bluetooth settings TURBINE : disposable STANDARD : ATS/ERS DATE format : dd/mm/yy UNITS format : cm, Kg Auto power-off : 60min • TO MODIFY THESE SETTINGS SELECT AND PRESS ENTER Delete data in memory To delete all the data in memory. The display will show: Use to quit without deleting the test data.
' # ' ' % ' % 8 1 A 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. SYRINGE VOLUME cL: 300 OLD FVC FIVC BTPS 0 0 New FVC FIVC %ERR .00 .00 ATP If FVC AND FIVC =0 then Use factory calibration %ERR BTPS ATP = TOTAL ERROR = Measure condition = Conversion from BTPS ESC to Quit = = ? =3 ? = ' 3 ' ' 91 / F( : ' 3 .) ' ? =3 ) 8 G3 .+ + 1 : 0 .
To 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. 1A % 8; ( 9 1 7 7 98; ( : ) . 7 2 - 9? =3 : J 1 7 K A 98; ( 2 7 F( 8;( 9 1 7 7 98 ; ( : ) . .7 2 9? =3 : J 1 1 .
PRINTER Options and having selected a device it is To control the devices memorized within the “printers list”. Enter the list with possible to set the device as default (so SpirolabIII will automatically connect to this) or to delete the device from the list (SpirolabIII asks for a confirmation by pressing delete the device from the list). , otherwise press to return to the Bluetooth options and not PHONE Options To control the devices memorized in the “printers list”.
After each test session the results are compared to the selected 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 be recalled from the SpirolabII’s memory. The best test result is determined following the ATS/ERS standards. In practice, the best test is the one having the highest sum of FVC+FEV1.
2.5.7 New subject data entry Press . The lower part of the screen will show the following message: CHANGE NEW SUBJECT NAME AND SURNAME or Use to modify data of a patient already inserted, or to enter the details of a new patient. Enter the required information using the cursor positioned on the subject’s surname. Use All data entered must be confirmed with use or cancelled with to go to the next entry. .
Select the spirometry test: To make the FVC test To make the VC/IVC and ventilatory profile tests To make the MVV test. When a test is being performed the display will show the real time Flow/Volume curve or the Volume/time curve. The test must begin within 30 seconds of pressing the start key, otherwise the test is interrupted and the device returns to the main screen. 2.6.1 Spirometry testing Insert a new mouthpiece into the MiniFlowMeter mouthpiece holder.
nd 2 case: subject file To perform a POST test on a patient already in memory, firstly “recall from memory” the relavant PRE test spirometry parameters from the same subject file. ; select FILE NO. from the PRE test. Confirm with Press . Press to activate the POST phase. When the POST phase is activated, the patient data are shown and “POST” appears on the upper left part of the screen.
!"# $ FLOW DROP 50% st If the flow rate falls (>50%) and then rises again during the 1 second of a forced expiry, this message is shown: % & ' ()*&) FET ERROR If the FET is less than the minimum (3 seconds), this message is shown: +& & , & ($ $ & '& FLOW ERROR If the last point of the F/V curve is greater than 200 mL/s, this indicates that the expiration was not complete and thus this message is shown: "# ( " " && " () 2.
If it is not possible to make the calculations for lack of data, the interpretation is not valid and this message appears: • Not Valid For more information on the methods of test interpretation see the attached flow chart. > 2.10 ' > OXIMETRY TESTING SpirolabIII can carry out different types of oximetry tests, which are described in the following paragraphs. SpirolabIII ' ) ) ' ) SpirolabIII ' M ' 3 2 ' "' . SpirolabIII ' = 0 ' ' .
Select required test with , using the vertical scroll arrow, press . ' ' ' ' During the first few seconds of the test the device searches for the best signal, after which the timer re-sets to zero and SpirolabIII starts to memorise the data.
• DISTANCE (m) These follow the Borg scale and can have the following values: 0, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, the distance covered is and to enter data; use to pass to next data. indicated in m. Use Walk test data results are given in the following screen, and can be printed as described in Paragraphs 2.13 and 3.1.2. if the test results are printed, the test printout will only show the walk test results; an example of a test printout report is attached. Press 2.10.2 to end the test at any moment.
• Fold the pad of the emitter probe over the tip of the patient’s finger. Separate the window of the emitter so that it is diametrically opposite the window of the detector. • Fold the adhesive wings downwards around the finger. Do not pull or stretch the adhesive tape. Check that the positioning lines of the emitter and of the detector are aligned.
FIND AND READ TESTS IN MEMORY Press to access menu, from where to view and to print all test data stored in the memory of the device. 2.12.1 Subject List by last name Subject List by ID code Memory List Subject List by name: This message appears: ENTER FULL OR PARTIAL SURNAME TO SEARCH MATCHING FILES Use keyboard to enter subject surname or first letters. All corresponding surnames found in memory will then be listed.
Generates the Flow/Volume curves of the last test. ' The data stored in the memory are those of the best tests. The current test can be printed by pressing . To print a test saved on file after recalling it press . To interrupt printing press . The printout report includes a header line with the date, time, the BTPS value at the time of the test, patient details, the FILE No., any pre-set ethnic correction factor and the predicted value set used.
• Use 3.1.3 to return to the main screen. Data Transmission through Bluetooth • From the main screen press • Use vertical scroll keys to select Bluetooth settings and press • • select “intended use” and press it is described the transmission way and ,if correct, it is required to confirm it with “OK” to activate the connection to the device choosen as default in the configuration menu.
= ( ' = % B3 % ' C =( 9 =( % : To make the connection insert the mini USB connector supplied with SpirolabIII as shown in the picture and attach the other connector to the USB port of the PC. At the first connection, the PC will request the installation of the driver corresponding to the new device being used; follow the automatic procedure in the operating system, enter the following path when the request for the driver appears. Windows 2000 and higher versions enter the following path: C\Programmi\
0 4.2 CLEANING THE REUSABLE TURBINE The turbine utilized with SpirolabIII is of one of two categories: disposable or reusable. These guarantee precise measurements and have the advantage of requiring no periodic calibration. In order to maintain these characteristics, a simple cleaning is required prior to each use (only for the reusable turbine). This operation also ensures perfect hygiene and thus the highest possible safety conditions for patients.
' 4.2.1 Recommended products for cleaning the reusable turbine Tests made on the cleaning of the turbine with various products have demonstrated that the best product in commerce which does not harm the material of the reusable turbine is: PERA safe After 100 immersions lasting 10 minutes each at an interval of 15 seconds, PERA safe did not cause any harm to the turbine. These test results are available from the MIR offices.
5 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 keys which regulate the brightness and the contrast of the display. The battery charging is not working correctly The device is protected thermically.
5 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, or upon delivery, and any claims must be made within 8 days in writing to the manufacturer.
ANNEXES DECLARATION OF CONFORMITY MEDICAL INTERNATIONAL RESEARCH Via del Maggiolino, 125 00155 - Roma - ITALIA srl Declaration of EC Conformity Quality Management System according to the requirements of Annex II of the Medical Device Directive 93/42/EEC.
EXAMPLE OF OXIMETRY TEST REPORT Spirolab III SpirolabIII – User’s Manual Code MIR 980067 REV 0 Page 43 / 47
INFORMATION FOR CORRECT USE IN AN ELECTROMAGNETIC ENVIRONMENT Guidance and manufacturer’s declaration – electromagnetic emissions The Spirolab III is intended for use in the electromagnetic environment specified below. The customer or the user of the Spirolab III should assure that it is used in such an environment. Emissions test Compliance Electromagnetic environment – guidance RF emissions Group 2 The Spirolab III must emit CISPR 11 electromagnetic energy to perform its indended function.
Guidance and manufacturer’s declaration – electromagnetic immunity The Spirolab III is intended for use in the electromagnetic environment specified below. The customer or the user of the Spirolab III should assure that it is used in such an environment. Immunity test IEC 60601 Compliance level Electromagnetic test level environment – guidance Electrostatic ± 6 kV contact ± 6 kV contact Floors should be discharge (ESD) wood, concrete or ± 8 kV air ± 8 kV air ceramic tile.
Guidance and manufacturer’s declaration – electromagnetic immunity The Spirolab III is intended for use in the electromagnetic environment specified below. The customer or the user of the Spirolab III should assure that it is used in such an environment.
Recommended separation distances between portable and mobile RF communications equipment and the Spirloab III The Spirolab III is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
