Related Manuals for Medical International Research Spirolab III
Summary of Contents for Medical International Research Spirolab III
- Page 1 Spirolab III User’s Manual Rev.0 Issued on 21/06/06 Approved on 21/06/06 SpirolabIII – User’s Manual Code MIR 980067 REV 0 Page 1 / 47...
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Page 2: Important Note
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 CODE PRODUCT with oximetry option CODE 672685 672685 SpirolabIII SpirolabIII device... - Page 3 Manufacturer’s address: MIR srl: Via Del Maggiolino, 125 00155 Roma, Italy Tel ++ 39 0622754777 Fax ++ 39 0622754785 e-mail: mir@spirometry.com SpirolabIII – User’s Manual Code MIR 980067 REV 0 Page 3 / 47...
- Page 4 INDEX INTRODUCTION................................. 6 GENERAL INFORMATION ............................6 Intended use ................................. 6 1.1.1 User Category ............................. 6 1.1.2 Ability and experience required ........................6 1.1.3 Operating environment ..........................6 1.1.4 Who can or must make the installation ....................... 6 1.1.5 Subject effect on the use of the device ....................... 6 1.1.6 Limitations of use - Contraindications ......................
- Page 5 Example of oximetry test report ............................ 43 Information for correct use in an electromagnetic environment ..................44 SpirolabIII – User’s Manual Code MIR 980067 REV 0 Page 5 / 47...
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Page 6: General Information
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. GENERAL INFORMATION NTENDED USE 1.1.1... -
Page 7: Important Safety Warnings
" & MPORTANT SAFETY WARNINGS SpirolabIII has been examined by an independent laboratory which has certified the conformity of the device to the European Safety Standards EN 601-1 and guarantees the EMC Requirements within the limits laid down in the European Standard EN 60601-1-2 SpirolabIII is constantly controlled during its production, therefore the product confirms to the established security levels and quality standards laid down by the Council Directive 93/42/CEE for medical devices. - Page 8 • • • • • • • • & " & & < & 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. In order to avoid exposing the subject to the critical danger of cross-contamination, the reusable flow sensor must always be cleaned before each spirometry test, and always use a new disposable mouthpiece for each subject.
- Page 9 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.
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Page 10: Labels And Symbols
SpirolabIII > 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). - Page 11 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).
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Page 12: Technical Specifications
TECHICAL FEATURES OF THE SPIROMETER Memory capacity for over 6000 spirometric tests. The Memory precise number depends on the individual configuration, so it cannot be determined more closely RS232, USB, Bluetooth Interface Flow/volume measurement system Bi-directional digital turbine Measurement method Infrared interruption Semiconductor (0-45°... - Page 13 *PEF Best PEF Forced Vital Capacity FEV1 Volume expired in the 1 second of the test FEV1% FEV1/FVC x 100 FEV1/VC% FEV1/VC x 100 Peak expiratory flow FEF2575 Average flow between 25% and 75% of the FVC FEF25 Forced Expiratory Flow at 25% of FVC FEF50 Forced Expiratory Flow at 50% of FVC FEF75...
- Page 14 T< 40 BPM Time passed with pulse frequency < 40 BPM % hh:mm:ss T> 120 BPM Time passed with pulse frequency > 120 BPM % hh:mm:ss N° Events < 40 BPM Bradycardia events during the entire analysis period N° Events > 120 BPM Tachycardia events during the entire analysis period Tot.
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Page 15: Product Description
Parameters required for walk test: SYMBOL DESCRIPTION Units Dyspnea Borg Baseline Grade of dyspnea before walking Dyspnea Borg End Grade of dyspnea after walking Fatigue Borg Baseline Level of fatigue before walking Fatigue Borg End Level of fatigue after walking Walked Distance covered during walking Parameters measured with SpO2 Analysis:... - Page 16 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., the percentage change between spirometry results obtained before and after the subject takes a drug) and the results of a bronchial challenge test or a bronchodilation test.
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Page 17: Miniflowmeter Sensor
ILLUSTRATION OF PIROLAB Display Thermal paper container Keyboard Miniflowmeter sensor Flow sensor compartment Oximeter sensor KEYBOARD SYMBOL DESCRIPTION On/Off Adjust contrast, press several times as required Adjust brightness, press several times as required Advance the printer paper Self-check key Cancel the current operation Select configuration menu Correction key/cancel last data inserted Information about options... -
Page 18: Charging The Battery
Specifies female sex Specifies male sex Confirm last operation. This key is the ENTER key Move cursor HARGING 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. - Page 19 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. Guide to the correct positioning of the paper roll holder Push the paper into the slot located under the traction reel (black rubber reel).
- Page 20 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;...
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Page 21: Configuration Menu
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 •... -
Page 22: Total Error
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 SYRINGE VOLUME cL: 300 BTPS BTPS %ERR %ERR... - Page 23 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. 8; ( 9 1 7 7 9 8; ( : ) . 7 2 - 9 ? =3 : J 1 7 K A 9 8; ( ? =3 : 2 7 F ( 8 ;...
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Page 24: Printer Options
PRINTER Options To control the devices memorized within the “printers list”. Enter the list with and having selected a device it is 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 , otherwise press to return to the Bluetooth options and not... -
Page 25: Date And Time
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. Measured % Predicted = x 100 Predicted The test can be repeated more than once and the best result is memorized in order to be recalled from the SpirolabII’s memory. - Page 26 2.5.7 New subject data entry Press The lower part of the screen will show the following message: CHANGE SUBJECT NAME AND SURNAME 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 to go to the next entry.
- Page 27 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.
- Page 28 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. Press ; select FILE NO. from the PRE test. Confirm with Press to activate the POST phase.
- Page 29 ! " # $ FLOW DROP 50% 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: + &...
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Page 30: Oximetry Testing
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. > >... - Page 31 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. For each type of test, if the sensor has not been correctly inserted, after a few seconds the following message will appear: WARNING...
- Page 32 • 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 indicated in m. Use to enter data; use to pass to next data. Walk test data results are given in the following screen, and can be printed as described in Paragraphs 2.13 and 3.1.2.
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Page 33: File Organization
• 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. -
Page 34: Memory List
FIND AND READ TESTS IN MEMORY 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. Subject List by last name Subject List by last name Subject List by ID code Subject List by ID code Memory List... -
Page 35: Data Transmission
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 . - Page 36 • to return to the main screen. 3.1.3 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.
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Page 37: Upgrade Internal Software
=( 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;... - Page 38 LEANING 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.
- Page 39 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.
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Page 40: Problems/Causes And Solutions
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. -
Page 41: Limited Warranty Conditions
If units are to be returned to the manufacturer then written or verbal permission must be received before any instruments are returned to MIR. MIR - Medical International Research reserves the right to modify the instrument if required, and a description of any modification made will be sent along with the returned goods. - Page 42 Notified body CERMET N° 0476 - Certificate of Conformity N° MED – 9826 MIR srl Medical International Research declares that the Device subject of this declaration together with its standard accessories conforms to the requirements of the Council Directive 93/42/EEC Annex I.
- Page 43 XAMPLE OF OXIMETRY TEST REPORT Spirolab III Spirolab III SpirolabIII – User’s Manual Code MIR 980067 REV 0 Page 43 / 47...
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Page 44: 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... - Page 45 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...
- Page 46 If the measured field strength in the location in which the Spirolab III is used exceeds the applicable RF compliance level above, the Spirolab III should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the Spirolab III.
- Page 47 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. The customer or the user of the Spirolab III can help prevent...
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Нужен сервисный пароль для очистки памяти ( не записывает исследования)
The service password for clearing memory on the Medical International Research Spirolab III is: 122333.
This answer is automatically generated