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MIR Spirolab 3 - Frank`s Hospital Workshop

1. AN TURBINE DC OUT 5V Bd N SpO FCC ID TUK MIROO9 Warning symbol for the turbine connector Use only and exclusively the original turbine flow sensor 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 An alternative is to return the device without charge to the dealer or distributor when it is replaced by another equivalent device Due to the materials used in the manufacturing of the device disposing it as a normal waste product could cause harm to the environment and or to health Failure to observe these regulations can lead to prosecution For connection to other devices such as PC or printer Use only the USB serial cable supplied by the manufacturer and observe the safety regulations of IEC 60601 1 1 Warning symbol for the SpO2 port for oximetry Warning symbol for the FCC spirolab JJ complies with Part 15 of the FCC Rules The correct operation is subject to the following conditions 1 this device must not cause harmful interference 2 t
2. Standard To select one of the available standards ATS ERS or NANHES III press PR DATE format dd mm yy To select the required format toggles between dd mm yy or mm dd yy or yy mm dd or vice versa Press 17 to toggle spirolab III User Manual Code MIR 980067 REV 1 6 Page 38 77 UNITS format cm kg To change the units format from cm kg to in Ib inches and pounds or vice versa Press 7 to toggle Auto power off 6 min To change the wait time for auto power off to 6 min 60 min or after 240 min Press 17 to toggle 2 5 6 Functioning of the spirometer spirolab ZII performs the following measurements Forced Vital Capacity Slow Vital Capacity The valuation and interpretation of test results are given by comparing the measured parameters with specific normal spirometry values known as o BPM predicted values which are calculated SPOR from subject data age height weight sex and ethnic group For the calculation of the predicted values there are several different sets available both for adults and for children For adults ERS European Respiratory Society Knudson Morris Bass Multicentrico Barcellona For children Knudson s Zapletal ec amp amp 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 peasured x 100 The test can be repeate
3. spirolab 77 User Manual Code MIR 980067 REV 1 6 Page 7 77 possible If these fundamental conditions are not respected then the results obtained during spirometry testing will not be accurate and therefore the test results are not acceptable The acceptability of a test is the responsibility of the user Special WARNING should be given to testing elderly subjects children and handicapped people The device should never be used when it is possible or probable that the validity of the results may be compromised due to any such external factors WARNING The instrument must be used as described in the User s Manual with particular WARNING to the paragraph on Intended Use utilizing only original spare parts and accessories as specified by the manufacturer may be used Use of non original parts such as the turbine sensor or other accessories may cause errors in measurement and or compromise the correct functioning of the device Any use of the device which differs from the original is to be considered improper and therefore dangerous The spirolab ZII when used as a pulse oximeter has limited alarms therefore the device requires frequent display observation of SpO2 and pulse rate 1 2 IMPORTANT SAFETY WARNINGS spirolab JJJ 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 i
4. 99 Longest Duration Desat s 0 Mean Desaturation 0 NOD 4 Delta SpC2 gt 4 00 00 00 Mean Drop SpO2 O NOD 89 lt 89 00 00 00 Max Drop SpO2 0 NOD 90 lt 90 Nadir lt 86 00 00 00 Made by spirolab III Signature spirolab III User Manual Code MIR 980067 REV 1 6 Page 71 77 INFORMATION FOR CORRECT USE IN AN ELECTROMAGNETIC ENVIRONMENT Guidance and manufacturer s declaration electromagnetic emissions The spirolab ZI is intended for use in the electromagnetic environment specified below The customer or the user of the spirolab 777 should assure that it is used in such an environment Emissions test Electromagnetic Compliance environment guidance RF emissions CISPR 11 Group 2 The spirolab 777 must emit electromagnetic energy to perform its indended function Nearby electronic equipment can be affected RF emissions CISPR 11 Class B The spirolab III is suitable for use in all establishments including domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes Harmonic emissions IEC 61000 3 2 Class D Voltage fluctuations flicker emissions IEC 61000 3 3 Complies spirolab III User Manual Code MIR 980067 REV 1 6 Page 72 77 Guidance and manufacturer s declaration electromagnetic immunity The spirolab
5. To enable or disable the printout of spirometry parameters in addition this menu allows to set up enable or disable the printout of the F V and V t curves Bluetooth settings Select this function and the following menu is shown spirolab III User Manual Code MIR 980067 REV 1 6 Page 36 77 e Search Device e Options PRINTER e Options PHONE e Remote line Number Search Device Select the required option with and confirm with y spirolab IJI begins to search for Bluetooth active devices when one or more active devices are found then a list is shown select a device and push to define the device with vertical scroll as a printer or as a phone 3 PRINTER or PHONE select one of the two options and push otherwise EX push J to return to the Bluetooth options If the device is already present in the chosen list a warning message will be shown on the display push a key to turn to the devices list Options PRINTER To control the devices memorized within the printers list Enter the list with 4 ang having selected a device it is possible e to set the device as default identified with a yellow point near the device name so spirolab II will automatically connect to this e to delete the device from the list spirolab III asks for a confirmation by pressing EX otherwise press to return to the Bluetooth options and not delete the device from the list If no devices are shown then a message advises the user to se
6. distance in metres m Field strengths from fixed RF spirolab III User Manual Code MIR 980067 REV 1 6 Page 75 77 transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equipment marked with the following symbol 9 NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people a Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the spirolab JII 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 Il b Over the frequency range 150 kHz to 80 MHz field strengths should be less than J V m spirolab III User Manual Code MIR 980067 REV 1 6 Page 76 77 Reco
7. ssessssssseeeeeenenemne 51 2 12 14 Subject List by lastname se imc hc ted Ee ri dies 51 2 42 2 SubjectList by ID code eee eere recte tet 52 2 12 39 Memory List emet tee tefte cedro tete ed ede ees 52 2 13 View and print results 2 2 eee ceeseeeeeeesecceeseseneeeenentenenseeeseedeeceeeeesseesenesseeeeeeseeeees 52 3 DATA TRANSMISSIQN 1 itn te Rn EH MLB IR TOREE EON GARD e MH EB relie iate 54 3 1 Data Transmission via Bluetooth to a cell phone e 54 3 1 1 Preliminary opetat ONS eaaa ae amaeana aaan atea aee Are iroa a aE Eroe EAA SiS EEE GF 54 3 1 2 Setting the Phone Number nennen nnns 54 3 1 3 Data Transmission through Bluetooth seeeene 54 3 1 4 Data Transmission via Bluetooth for printing 55 3 2 Connection toa pe witch ei UL eMe Bue Deinen PERDE rase ERU ceo recat De Rue eats 55 3 2 1 Connection to a PC through a USB port ssssse 56 3 2 2 Connection to PC through RS 232 port sssssssseee 56 3 3 Upgrade internal software sse eee nenne 56 4 MAINTENANCE AND CLEANING eene enne nre 56 4 1 Cleaning the device ssessssssseseeeeseeeee nennen nnne nennen nennen entente nnne nnns 57 4 2 Cleaning the reusable turbine ssssseseeeeeeeeneeen eene 57 4 3 Cleaning and disinfection of the oximetry sensor 59 5 PROBLEMS CAUSES AND SOLUTIONS esee nennen 60
8. 90 for continue NOD 90 i periods above 5 minutes with minimum value hh mm ss A DELTA Parameters measured during exercise test DESCRIPTION Units SYMBOL SpO2 Baseline SpO2 average before exercise BPM Min Pulse frequency minimum during exercise Time passed with SpO2 lt 90 spirolab III User Manual Code MIR 980067 REV 1 6 Page 21 77 analysis Baseline Time Duration of baseline phase Time for SpO2 value 2 99 of the average base value calculated during the initial phase of the hh mm ss est Recovery Time DYSPNEA CHG Variation in grade of dyspnea during exercise Fatigue CHG Variations in level of fatigue during exercise N A DELTA Parameters required for exercise test SYMBOL DESCRIPTION Units Final DYSPNEA rade of dyspnea after exercise Parameters measured with SpO2 Analysis SYMBOL DESCRIPTION Unit Recording time otal time measure of SpO2 spirolab III User Manual Code MIR 980067 REV 1 6 Page 22 77 Bradycar Events 4 BPM Tachycar Events 120 BPM Acoustic signals for oximetry e Beep with frequency of the cardiac pulse e Continuous beep in the case of either 96SpO or cardiac pulse going outside of the programmed alarm levels e Continuous beep during oximetry measurement in the case of low battery level e Ifthe patient s finger is not inserted correctly or the connecter is not properly attached there will be an intermittent beeping s
9. DEVICES In the event of any accident caused by the device the user must inform the manufacturer without delay 1 4 LABELS AND SYMBOLS Identification label of the spirometer model Spirolab 7 SN A23 053 00000 ae SN A23 054 00000 ANN MIR REF spirolab colour AS MIR REF spirolab ZI b w MEDICAL INTERNATIONAL RESEARCH FCC ID TUK MIROOS MEDICAL INTERNATIONAL RESEARCH FCC ID TUK MIROOS Rx ONLY Rx ONLY Madey sR Made by Mt bess C oaze A omis Pome AY C Eoaze 4 For color display For black and white The identification label located on the underside of the casing shows the product name plus the following e Manufacturer s name and address e Mark of conformity with the directive 93 42 EEC e Serial number of the device C EC mark for medical devices This product is certified to conform to the requirements of the 93 42 EEC medical 0476 devices directive Electrical safety symbol In accordance with IEC 60601 1 this product and its component parts are of type BF and therefore protected against the dangers of direct and indirect contact with electricity F CER Warning symbol for the connection of the power supply e e C 5 To charge the internal battery use only and exclusively the N i original power supply 12 V 1A DC MIR code 920665 DC IN 12 V guaranteed and certified to the EN 60601 1 Safety Standard spirolab III User Manual Code MIR 980067 REV 1 6 Page 15 77
10. FUNCTION PRE The first test for each new subject is a PRE type i e without drug administration For the POST test i e after the administration of drugs see Paragraph 2 6 2 POST in this Manual FILE spirolab III assigns a progressive number to each new PRE POST or SpO2 BPM oximetry test LAST NAME AND NAME Are displayed data of the last patient inserted D Indicates the subject number or identification code which is inserted by the user TYPE OF TURBINE STANDARD IN USE BTPS Body Temperature Pressure Saturated 2 5 7 New subject data entry spirolab III User Manual Code MIR 980067 REV 1 6 Page 40 77 Press o The lower part of the screen will show the following message CHANGE NEW Use K or p to modify patient data of patient displayed otherwise insert new details SUBJECT NAME AND SURNAME Use K or p 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 7 to go to the next entry All data entered must be confirmed with 4 or cancelled with cme To modify a number after it has been entered use to return the cursor to the area required to enter the correct numerical value and go to the next entry press qa 1D Insert the patient ID code this code is alphanumerical and can be a maximum combination of 16 characters this code enables the quick recall of any patient data when
11. FVC FEV1 FEV1 FEV6 FEV6 FEV3 FEV3 FEV1 FEV6 FEF25 FEF50 Vext FIVC FIV1 FIV1 PIF FEV1 VC e Parameters stored with the VC test o VC IVC EVC EVC or IVC ERV IC TV VE fr ti te TV ti te tt e Parameters stored with the MVV test o MVV e Points of the expiratory part and if present the inspiratory part of the Flow Volume curves plus the points of the Volume time curve e Parameters stored with the SpO2 test in relation with the test recorded see also paragraph 1 6 2 WARNING A All of the parameters are always stored even if not all of the tests were performed in this case the results of those parameters are stored as zero The symbol indicates the best result of that subject Spirometry results can be recalled from the memory FILE To access the database press The results of the selected test can be printed by pressing after visualization on display spirolab III User Manual Code MIR 980067 REV 1 6 Page 56 77 2 12 SEARCH AND READ TESTS IN MEMORY FIND AND READ TESTS IN MEMORY gt Subject List by Last Name Subject List by ID code List by date The research can be made in three different Memory List manners Bluetooth transmission m Press to access menu from where to view all test data stored in the memory of the device Subject list by last name Subject list by ID code List by date Memory list CHOOSE ANY FUNCTION Using amp and NM select the method
12. UT for 5 sec Power frequency 50 60 Hz magnetic field IEC 61000 4 8 3 A m 3 A m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment NOTE UT is the a c mains voltage prior to application of the test level spirolab III User Manual Code MIR 980067 REV 1 6 Page 74 77 Guidance and manufacturer s declaration electromagnetic immunity The spirolab J is intended for use in the electromagnetic environment specified below The customer or the user of the spirolab 777 should assure that it is used in such an environment Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Conducted RF IEC 61000 4 6 Radiated RF IEC 61000 4 3 3 Vrms 150 kHz to 80 MHz 3 V m 80 MHz to 2 5 GHz 3 V 3 V m Portable and mobile RF communications equipment should be used no closer to any part of the spirolab III including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance 3 5 NP 3 3 5 NP 80 MHz to 800 GHz 3 d4 Z NP 800 MHz to 2 5 GHz 3 where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation
13. User Manual Code MIR 980067 REV 1 6 Page 66 77 Make sure that the turbine s cable is connected to the spirometer and that the plug is inserted properly in the appropriate connector Make sure that the turbine is inserted correctly into the MiniFlowmeter The device does not measure correctly Make sure the turbine is inserted correctly in the MiniFlowmeter Verify the free movement of the turbine as illustrated in Paragraph 4 2 WARNING A In case the device does not resume correct functioning in spite of the controls made contact the manufacturer or an authorized service centre WARNING A Before contacting the centre for technical assistance please download the archive from the device on to the PC using the Winspiro PRO software This procedure is necessary as the data could be lost whilst repairing the device and could also be of a confidential nature and therefore subject to laws on data privacy spirolab III User Manual Code MIR 980067 REV 1 6 Page 67 77 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 manufac
14. ZI is intended for use in the electromagnetic environment specified below The customer or the user of the spirolab 777 should assure that it is used in such an environment Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Electrostatic discharge ESD 6 kV contact 6 kV contact Floors should be wood concrete or ceramic tile t 8 kV air t 8 kV air If floors are covered with IEC 61000 4 2 synthetic material the relative humidity should be at least 30 Electrical fast 1 kV for 1 kV for Mains power quality transient burst input output input output should be that of a lines lines typical commercial or IEC 61000 4 4 hospital environment Surge t1kV 1 kV differential Mains power quality differential mode should be that of a IEC 61000 4 5 mode typical commercial or hospital environment t 2 kV common t 2 kV common mode mode Voltage dips 5 UT 5 96 UT short gt 95 dip in 295 96 dip in UT interruptions and UT for 0 5 cycle voltage variations for 0 5 cycle on power supply 40 96 UT input lines 40 96 UT 60 96 dip in UT 60 96 dip in for5 cycles IEC 61000 4 1 1 UT for 5 cycles 70 UT 30 96 dip in UT 70 UT for 25 cycles 30 96 dip in UT 5 96 UT for 25 cycles gt 95 96 dip in UT for 5 sec spirolab III User Manual Code MIR 980067 REV 1 6 Page 73 77 lt 5 96 UT gt 95 96 dip in
15. a cell phone which then transmits the data to a PC by modem etransfer to a Bluetooth enabled printer spirolab III User Manual Code MIR 980067 REV 1 6 Page 59 77 The following paragraphs contain in depth information on these two procedures 3 1 D ATATRANSMISSION VIA BLUETOOTH TO A CELL PHONE spirolab IIT can be connected to a cell phone with this system installed The transmission of data with this technology allows the transfer of all data in memory of the spirolab ZI The sequence of operations to follow is described below 3 1 1 Preliminary operations WARNING A The transmission of data through a Bluetooth connection requires the phone number of the unit where the data shall be transferred the doctor s office telemedicine service etc The phone number is set up from the Configuration Menu see Paragraph 2 5 5 A device must also be setup for the connection refer to Paragraph 2 5 5 for further details 3 1 2 Setting the Phone Number MENT With spirolab III switched on press per Use vertical scroll key to select Bluetooth settings then press qa Use vertical scroll key to select insert telephon number then press Enter the number with the numerical keyboard and again press qu the Bluetooth Menu will appear eL EX e Use Lee to return to the main screen 3 1 3 Data Transmission through Bluetooth FILE e From the main screen press e Use vertical scroll keys to select Bluetooth transmission a
16. after finishing the spirometry testing When the flow sensor head is not in use we recommend that it is kept in its compartment Press lightly on the connector to detach the flow sensor turbine from the socket on the left hand side of the device and proceed with the cleaning operations as outlined in the MAINTENANCE CLEANING section of the manual 2 5 4 Switching off the spirometer The device has an auto power off system for reducing battery consumption This feature can be set up from the menu by selecting one of the following 3 options 6 60 or 240 minutes the device will automatically switch off upon reaching the pre set time when no activity has been made for that time spirolab III User Manual Code MIR 980067 REV 1 6 Page 31 77 If instead the device remains switched on when all operations are complete switch it off manually by pressing When the device is switched off the green LED indicator on the right hand side of the on off key should also be off When the battery does not need charging then be sure to detach the power supply from the power supply socket on the back of the device and remove the charger from the mains supply 2 5 5 Initial settings WARNING A The sections of this Manual contained in a frame correspond to the wording shown on the screen of the device spirolab II allows for the personalised setting of certain parameters through the Configuration Menu MEN To access the con
17. case of an FVC test after making at least two valid tests the reproducibility of the parameters FVC FEV1 and PEF is also shown VC IVC and Ventilatory Profile tests It is possible optional to begin the test by making several complete breaths at rest After three or four similar breaths a message VC IVC on the display will indicate that the ventilatory profile has been measured and you can now proceed to carry out the VC or IVC test VC test When the message VC IVC appears inspire slowly as much air as possible into the lungs and then expire slowly as much air as possible spirolab III User Manual Code MIR 980067 REV 1 6 Page 43 77 IVC test When the message VC IVC appears expire slowly as much air as possible and then inspire slowly as much air as possible EK To end the test press or wait 3 seconds after the last volume cycle If you make the test without the ventilatory profile respiratory function at rest then the measured parameter will be only VC or IVC Instead by carrying out several complete breaths at rest then in addition all measured parameters of the ventilatory profile will be given During the test the volume time curve is displayed MVV Start the test by carrying out a series of forced inspirations and expirations with the maximum possible amplitude The suggested frequency is 30 breaths min The test will terminate automatically after 12 seconds ES To end test press or wait 3 seconds after t
18. curves can be printed out in seconds by the built in thermal printer The Flow Volume curve is shown in real time on the display 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 A comparison of data is made between POST after drug and PRE before drug administration The flow and volume measurement sensor is a digital turbine based on the infrared interruption principal This principal ensures the accuracy and the reproducibility of the measurements without requiring a periodic calibration The main features of this kind of sensor are listed below e Accurate measurement even at very low flow rates end of expiration e Not influenced by gas humidity nor density e Shockproof and unbreakable e Inexpensive to replace The turbine flow measurement sensor is available both in reusable and in single patient disposable versions B v L Xs REUSABLE TURBINE DISPOSABLE TURBINE The following precautions must be observed to ensure that the characteristic
19. file FILE Press select using one of the research metods the PRE file Confirm with 47 Press p ID POS f to set a new test with the same patient Press n to activate the POST phase When the POST phase is activated the patient data are shown and POST appears under file number WARNING A In the POST phase the FVC VC and MVV tests can be performed Fvce ve Mvv In the POST phase having selected one of these three tests m ES or en the administered drug dose must be entered Whenever the test is repeated using the same dose the best test related to the dose used is saved When the dose is changed then a new record is made with a progressive FILE number For example if three tests are made on a subject at different doses then three different records POST tests are saved for that subject Afterwards the separate best POST tests can be viewed The subject code in the POST test is the same as for the related PRE test The results allow the confrontation of the spirometry parameters calculated in the POST test against the best results obtained in the PRE test already present in the patient archive for that session session refers to tests carried out on that day It is not possible therefore to carryout a POST test on a patient if the patient archive only contains PRE tests carried out only on previous days When the results are displayed it is possible to see the variation between the PRE and POST values shown in colu
20. is 20 C the FIVC syringe value 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 by the machine is converted to BTPS conditions so that the increase of the results with respect to the expected values does not constitute an error spirolab III User Manual Code MIR 980067 REV 1 6 Page 35 77 For instance if the calibration procedure is carried out with measured data 20 C FVC 3 08 FIVC 3 30 un spirometer is perfectly calibrated and the relative correction factors are null of calibration is required This does not represent an error but is a logical consequence of the above detailed ll explanation Printer header text PRINTER HEADER TEXT To insert a header that will be printed at the INSERT YOUR PRINTE HEADING beginning of each spirometry report see image USING UP TO 40 CHARACTERS Change DATE TIME To change the date and time The time is shown in the 24 hour format Select language To change the language used for displaying messages on the screen and the printouts Select predicted values To select one of the standards available for the calculation of the predicted values The parameters are organized in the following way REFERENCE ADULTS CHILDREN Knudson Select with the numeric keys the reference number automatically the chosen values will set and the display shows the configuration menu Select printout
21. minimum 3 seconds this message is shown Expiry time insufficient FLOW ERROR If the last point of the F V curve is greater than 200 mL s this indicates that the expiration was not complete and thus this message is shown Blow out all air in lungs 2 8 REPEATABILITY OF THE FVC TEST Following the international ATS and ERS standards it is recommended to repeat each FVC test at least 3 times to ensure the reliability of the spirometry test results The device helps the user through the reproducibility control check Between tests the repeatability of the following parameters is calculated PEF repeatable when the difference between the two largest PEF is lt 0 67 L s VC repeatable when the difference between the two largest VC is 150 mL If FVC is gt 1 0 L then FEV1 repeatable when the difference between the two largest FEV1 is lt 150 mL FVC repeatable when the difference between the two largest FVC is lt 150 mL if FVC is s 1 0 L then FEV1 repeatable when the difference between the two largest FEV1 is s 100 mL FVC repeatable when the difference between the two largest FVC is lt 100 mL 2 9 METHOD OF MEASUREMENT AND INTERPRETATION spirolab III User Manual Code MIR 980067 REV 1 6 Page 47 77 The device uses the infrared interruption principle of measurement with two sets of optoelectronic transmitters and receivers A pair of deflectors positioned at the entry and at the exit of the turbine tube generates a v
22. otherwise a single test pressing the number on numeric keys then press qa A V Read fie N E 2 13 VIEW AND PRINT RESULTS WARNING A During a test session the device will automatically memorize up to 8 FVC tests Press to view the results arranged in 8 sections on the screen Each of the tests can be viewed and printed These tests are numbered from 1 to 8 where test 1 represents the best test and 8 represents the worst test The last test made is always highlighted in green During the test session press C which recalls the best test the device will always show the graphs and results of the 3 best tests Each of the 3 tests can viewed and printed At the end of the test session when either a new subject is inserted or you pass to the POST phase the 3 best tests corresponding to the previous session are automatically saved on file These can be successively recalled from memory and viewed or printed either together or separately amp From the main screen it is possible to re examine and to print all the spirometry parameters Ra Generates the Flow Volume curves of the best test spirolab III User Manual Code MIR 980067 REV 1 6 Page 58 77 O erstes the Flow Volume curves of the last test WARNING A All tests results saved on file can be recalled viewed and printed The data stored in the memory are those of the best tests The current test can be printed by pressing s To print a te
23. the spirometer spirolab III User Manual Code MIR 980067 REV 1 6 Page 18 77 Measured parameters SYMBOL DESCRIPTION Units Volume expired in the 1 second of the test Peak expiratory flow Forced Expiratory Flow at 50 of FVC Extrapolated volume FIV1 FIVC FIV1 EIVC x 100 Slow vital capacity expiratory Respiratory frequency Breath min Average flow of inspiration at rest best values 1 6 2 Features of the oximeter spirolab III User Manual Code MIR 980067 REV 1 6 Page 19 77 d and infrared absorption Measurement method Range of measurement SpO calculation Range of measurement of cardiac pulse 30 254 BPM with 1 BPM ncrements Average interval for the calculation of cardiac ulse 8 seconds Definitions DESCRIPTION SpO2 Maximum during analysis period Minimum pulse frequency during the analysi eriod aximum pulse frequency during the analysi BPM Max BPM Mean Total time of analysis Time passed with SpO2 lt 88 96 ndex of SpO2 fluctuation calculated in interval spirolab III User Manual Code MIR 980067 REV 1 6 Page 20 77 Tachycar Events gt 120 Tachycardia events during the entire analysi Total Desat Events Mean Duration Average duration of desaturation events hh mm ss Time passed with SpO2 89 for continue baia eriods above 5 minutes n T ime passed with SpO2 lt
24. then the cursor automatically pass to the next value if a value must not be modified press p once the four values have been set up you can then if required activate or disactivate the acoustic alarm by pressing key 1 for OFF and key 2 for ON To confirm the selection press p Then is possible to set the sampling time press key 2 to set 2 A s Sec or press key 4 to set 4 sec Pressing the configuration menu is displayed Incentive spirolab IIT has a pediatric incentive program which can be useful to help a child or an older person make a correct spirometry test The incentive is a hidden image directly connected to the signal coming from the MiniFlowmeter so the harder the expiration then the further the curtain moves away revealing the image and thus helping the patient to obtain the best possible result When the pediatric incentive is selected a warning message is shown asking for the age of the patient Set the correct value the configuration menu is then shown Given that the FVC test requires collaboration that is difficult to obtain in children under the age of 4 then if an age of 4 or below is selected then spirolab ZI automatically shows the incentive during the FVC test Turbine setup Select the type of turbine to be used for testing either single patient disposable or reusable To select the correct option follow the steps as described previously selecting the required item and press v to change the option
25. together with its standard accessories conforms to the requirements of the Council Directive 93 42 EEC Annex I Device Description Spirometer Device name spirolab III Classification lla This device is marked with C 0476 Any modifications to the Device which are not authorised by us will invalidate this declaration Roma 01 09 2006 Signature Signature LaS A A J gaa rd Lawe Cato Simon Fowler Carmine Cerullo Sales Manager Quality Manager spirolab III User Manual Code MIR 980067 REV 1 6 Page 70 77 EXAMPLE OF OXIMETRY TEST REPORT Oximetry Sleep Test DATE 24 08 06 TIME 16 10 NAME Kkkl Iou Ver 0 5 01 05 1975 ID 2 HEIGHT cm 180 SEX M WEIGHT Kg 78 BIRTH DATE AGE 31 SpO2 Graph 853388955 1 2 3 Pulse Rate Graph 1 2 3 4 5 6 8 minutes Recording Time 00 05 00 Analysis Time 00 04 58 SPO2 BPM Baseline 97 8 Mean 97 7 Baseline 62 1 Mean 64 2 Minimum 97 Maximum 99 Minimum 56 Maximum 82 N SpO2 Events lt 89 0 N Bradycardia Events lt 40 BPM 0 Delta Index 12 sec 3 N Tachycardia Events 120 BPM 0 time hh mm ss time hh mm ss T90 SpO2 lt 90 0t 00 00 00 T 40 BPM 0t 00 00 00 T89 SpO2 lt 89 0t 00 00 00 T 5120 BPM 0t 00 00 00 T88 SpO2 88 o 00 00 00 T87 SpO2 lt 87 ot 00 00 00 Total Desaturation Events 0 Total Pulse Rate Variations 1 ODI Desaturation Index 0 Pulse Rate Variation Index 12 0 Mean Duration Desat s 0 Desaturation Peak Nadir
26. with P then press pa From this display it is also possible make the archive transmission with Bluetooth connection using a cell phone please see paragraph 3 1 2 12 1 Subject List by last name This message appears INSERT LAST NAME OR THE FIRST LETTERS OF LAST NAME TO FIND ALL MATCHING FILES IN MEMORY Use keyboard to enter subject surname or first letters All corresponding surnames found in memory will then be listed The first column on the right will show the file numbers corresponding to the tests made use numeric keyboard to enter required test press 47 to view related values Print selected test results using the internal printer by pressing s pressing twice the data are print on the external printer via Bluetooth system 2 12 2 Subject List by ID code The following message appears ENTER ID CODE OR PARTIAL TO SEARCH MATCHING FILES Enter subject ID and press 17 to view the list containing all file linked with the patient spirolab III User Manual Code MIR 980067 REV 1 6 Page 57 77 The data can be printed like described previously 2 12 3 Memory List MEMORY LIST NAME DATE TIME The screen will show the complete test memory list Indicate FILE No to view corresponding spirometry test results and press The data can be printed like described previously The data shown can be printed individually or in group it is possible to print a sequence of tests pressing the keys of the first and the last
27. 1 5 Subject effect on the use of the device 7 1 1 6 Limitations of use Contraindications sesseeeeeenenee 7 1 2 Important safety warnings sssseeeeenenen ener nnne 8 1 2 1 Danger of cross contamination sesseeeem een 10 1 2 2 HJ 11 1 2 3 MouthpleCe 2 eet rige e IM OR EGER ESR 11 1 2 4 Oximelry SenSOfs onte net cire Die eve So cate certo Ie deena hte 12 1 8 problems and unforseen errors ssssseeeneenneen nemen 13 1 4 LABELS AND SYMBOES aient dct ete eco te E ue EE 14 1 5 techical features of the spirometer sssssssseeeeeneneen ene 16 1 6 technical specifications iiipin ER HRRARRERU RERO nihic iapa ER IRR 17 1 6 1 Features of the spirometer seeseseesesseeeeeeene nennen nnne nnne 17 1 6 2 Features of the oximeter seeesssesseeeeee eene ener nennen nnne 18 2 PRODUGTDESORIPTION 2 eese tb Fe cates enh b DE eise pe bees rt boe sace rods 22 2 1 ILLUSTRATION OF Spirolab ll s eene 24 2 2 keyboard hate dote paeem edi t ree lan ote deo Ese cett a 24 2 3 Gharging the battery ine rentre cepe Een ente Eger eec 25 2 4 Switching on the spirometer sseeeeeeeeneneneneen eene 26 2 5 2 SOUINGS ou oec e E OR EE aed AE oie DUE EE E E 26 2 5 1 Gontrast settings etcetera pedea 27 2 5 2 Loading the thermal paper 27 2 5 3 Connecting the flow se
28. 5 77 2 1 ILLUSTRATION OF SPIROLAB IIT 1 MiniFlowmeter sensor 2 Thermal paper container 3 Flow sensor compartment 4 Display 5 Keyboard 6 Oximeter sensor 2 2 KEYBOARD ae c Oo OOo LDE RORS EcE ERE a Seo ooo 0 SYMBOL DESCRIPTION Advance the printer paper spirolab III User Manual Code MIR 980067 REV 1 6 Page 26 77 Cancel the current operation Select configuration menu Correction key cancel last data inserted Information about options View data in memory Enter modify patient data View best test View last test View last oximetry test Make POST test Make oximetry test Make VC test Make MVV test Number keys Specifies female sex 2 3 CHARGING THE BATTERY WARNING A spirolab 77 is powered only by the internal batteries the battery charger is used only to charge the internal batteries In the charging phase the device can be used only after the internal batteries have recovered a minimum charge level spirolab III User Manual Code MIR 980067 REV 1 6 Page 27 77 WARNING A For charging internal battery of spirolab 777 use exclusively the battery charger provided with the device MIR code 920665 eee 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 th
29. 5 LIMITED WARRANTY CONDITIONS sessseeeeeeeeeeneennnee nennen nenne nnne nnns 62 nimi E G 64 Declaration or conformity un cie ree reden a et bebe bere Debe vn 64 Example of oximetry test report cceecccceceseeceeeeeseeceeeeeeeeeeeseneeseseneeeenseneeseeeeseneeseseesenees 65 Information for correct use in an electromagnetic environment eeseeeees 66 N spirolab ZII User Manual Code MIR 980067 REV 1 6 Page 5 77 INTRODUCTION The spirometers series MIROO9 are sold with the spirolab III trademark spirolab JJI is available with two different displays e Colour LCD display e B W LCD display Unless otherwise specified from this point onwards the term spirolab JI is used to refer to both models 1 GENERAL INFORMATION 1 1 INTENDED USE Spirolab Ill spirometer and pulse oximeter is intended to be used by either a physician respiratory therapist or technician The device is intended to test lung function and can make e spirometry testing in people of all ages excluding infants and neonates e oximetry testing in people of all ages It can be used in any setting 1 1 1 User Category spirolab III spirometer pulse oximeter calculates a series of parameters relating to human respiratory function 1 1 2 Ability and experience required The correct use of the device the interpretation of the results and the maintenance of the device with par
30. ATORY JOURNAL Volume 6 Supplement 16 March 1993 Standardized Lung Function Testing 5 3 WARNING A By entering the number 0 zero no ethnic correction will be made to the calculation of the predicted values It is possible to enter ethnic group no 10 and to define a correction percentage of the predicted values between 50 and 200 of the predicted values in use WARNING A Note the settings pre defined within the configuration menu when inserting patient data in particular re date format weight and height 2 5 8 Modify subject data 13 ID To modify subject data press and then d All data not to be modified must be confirmed by pressing mE 2 6 SPIROMETRY FVC VC IVC MVV All subject data must be entered before carrying out a spirometry test The test can be made from the main screen or from any display that shows a previous test result last test best test or test in memory Select the spirometry test Fvce re To make the FVC test ve To make the VC IVC and ventilatory profile tests spirolab III User Manual Code MIR 980067 REV 1 6 Page 42 77 Mvv 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 if the pediatric incentive is set then the volume time curve is displayed The test must begin within 30 seconds of pressing the start key otherwise the test is interrupted and the device returns to the main
31. III User Manual Code MIR 980067 REV 1 6 Page 77 77
32. Shake off the excess water from the turbine and leave it to dry standing it vertically on a dry surface To ensure that the turbine is functioning correctly before replacing it inside the instrument it is good practice to make a visual check of the rotation blade Placing the turbine tube horizontally and moving it gently from left to right and vice versa the rotation blade rotor must rotate freely Otherwise accurate measurement is no longer guaranteed so the turbine must be replaced Once the turbine has been cleaned insert the turbine tube in its place following the instructions indicated by the lock symbol printed on the MiniFlowmeter To insert the turbine correctly push it and then turn it clockwise until reaching the stop which ensures that the tube has been blocked inside the casing Verify the free movement of the turbine e Switch on spirolab III as if to make a spirometry test for example FVC spirolab III User Manual Code MIR 980067 REV 1 6 Page 64 77 e Hold the MiniFlowmeter in one hand and move it gently from side to side so that air passes through the turbine e If the rotor within the turbine is turning correctly then you will hear a beep that indicates that the turbine is moving within the specific low flow range e f moving the turbine from side to side at a constant velocity regular beeps or no beeps at all are heard then proceed with the cleaning of the turbine WARNING A If the disposable
33. al scroll arrow If this message appears OXIMETRY NOT DETECTED then your instrument does not include an oximeter If this message appears OXIMETRY DISABLED the function has not been enabled In this case contact a service centre or the manufacturer WARNING A Before starting the test check to see that the battery is fully charged if it is low the following message will be shown Batteries are low and may not be sufficient for an oximetry test In this case select ESC to exit the test by pressing any key you can continue with the test already set up If the test is interrupted due to low battery charge the following message will appear on the display when the device is switched on again The last oximetry test was interrupted before being properly completed spirolab III User Manual Code MIR 980067 REV 1 6 Page 50 77 A beeping sound will be simultaneously heard for 10 seconds Afterwhich the spirolab JZ main screen will appear The oximetry tests that can be performed by Spirolab ZII are SPOT OXIMETRY SLEEP OXIMETRY EXSERCISE OXIMETRY SPOT OXIMETRY MEMORIZED LIKE OXYTEST here ee Choose required test pushing corresponding number on numeric key board During the test the display shows the informations like in the following image The number of blocks shown next to the SpO2 value are proportional to the signal quality maximum 8 blocks Position the finger within the sensor in order to
34. arch for active devices press ESC to start the search or to return to the Bluetooth settings Options PHONE To control the devices memorized in the printers list Enter the list with 47 ang having selected a device it is possible e to set the device as default identified with a yellow point near the device name and spirolab IIT will automatically connect to this e to delete the device from the list spirolab III asks for a confirmation by pressing ES otherwise press to return to the Bluetooth options and not delete the device from the list qu Even if the list is empty a search can be made for active devices as previously described Remote line Number spirolab III User Manual Code MIR 980067 REV 1 6 Page 37 77 Enter the menu with then it is possible to insert the telephone number that spirolab ZH will use to connect to a Bluetooth telephone Insert the required number using the numeric keyboard and then press Oximetry settings This function permits the following kinds of setting up e reference values for Sp02 and BPM if during a test these values go below the minimum or above the maximum values in the set up an acoustic alarm will ring to alert the user e activation disactivation of the acoustic alarm e set the sampling time 2 or 4 seconds of oximetry values during a test The cursor at the beginning will rest on the minimum Sp02 value use the numeric keys to select the desired value
35. cribed in Paragraphs 2 13 and 3 1 2 if the test results are printed the test printout will only show the exercise test results an example of a test printout report is attached Ex Press to end the test at any moment At the end of the test are shown calculated and inserted data with more than one display Use KI or p to read the various data WARNING A One of the parameters calculated by the Spirolab III during an oximetry test is the so called Recovery Time The Recovery Time is defined as the time taken for the spirolab III User Manual Code MIR 980067 REV 1 6 Page 55 77 SpO2 value to return to at least 9996 of the average base value calculated during heJ initial phase of the test a 2 10 4 Spot oximetry MEMORIZED LIKE OXYTEST This test is the same described in 2 10 1 the only difference is that the test is without subject data in the archive the test is memorized with the name OXYTEST The parameters calculated are like in spot oximetry see 2 10 1 2 11 FILE ORGANIZATION The memory of the spirometer is a string of memory areas called records each of which contain information regarding a single test session More specifically each record is made up as follows Demographic details of the subject Date time and ambient temperature at the time of the FVC test Reproducibility and quality control test information Parameters stored with the FVC test o FVC FEV1 PEF FEF75 FEF2575 FET PEF
36. d in which the device is not in use The repair or replacement described in this warranty is supplied for goods returned at the customers expense to our certified service centres For details of these centres please contact your local supplier of the spirometer or contact the manufacturer directly The customer is liable for all repairs not included under the terms of this guarantee The customer is responsible for all transportation charges Any instrument or accessory returned must be accompanied by a clear and detailed explanation of the defect or problem found If units are to be returned to the manufacturer then written or verbal permission must be received before any instruments are returned to MIR spirolab III User Manual Code MIR 980067 REV 1 6 Page 68 77 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 spirolab III User Manual Code MIR 980067 REV 1 6 Page 69 77 ANNEXES DECLARATION OF CONFORMITY MEDICAL INTERNATIONAL RESEARCH MIR s via del Maggiolino 125 00155 Roma ITALIA Declaration of EC Conformity Quality Management System according to the requirements of Annex Il of the Medical Device Directive 93 42 EEC Notified body CERMET N 0476 Certificate of Conformity N MED 9826 MIR srl Medical International Research declares that the Device subject of this declaration
37. d more than once and the best result is memorized in order to be recalled from the spirolab III 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 All tests are analyzed by applying the quality criteria quality control following the ATS standards In addition the reproducibility of the FEV1 FVC and PEF parameters are also calculated It is possible to perform POST drug testing in this case the test results are compared to a test made prior to the administration of drugs PRE test spirolab JI displays and prints the Flow Volume and the Volume time curves superimposed with PRE and POST parameter comparison and percentage of change spirolab III User Manual Code MIR 980067 REV 1 6 Page 39 77 Value POST PRE x 1 i Value PRE 29 After switching on the device the main screen will Spirolab III ven v xy show a summary of the current patient data DATES Some values shown are as follows DATE 23 09 06 TIME 12 44 00 FILEN 1 v X y e MEMORY o o A Indicates the version of the software firmware inside the spirometer In case of technical problems always LAST NAME note this version number FIRST NAME ID BIRTH DATE DATE AND TIME HEIGHT cm 0 The current date and time which can be modified from WEIGHT kg 0 the Configuration Menu TYPE OF TURBINE REUSABLE STANDARD IN USE ATS ERS BTPS 1 087 CHOOSE ANY
38. de MIR 980067 REV 1 6 Page 62 77 e Cleaning of the oximetry sensor for reusable sensors e Changing the adhesive tape of the oximetry wrap sensor e Changing the battery The maintenance operations described in the User s Manual must be carried out carefully Failing to observe the instructions may cause errors in measurement or in the interpretation of measured values Modifications adjustments repairs and reconfiguration must be carried out by the manufacturer or by authorised persons In case problems arise never attempt to repair the unit The setting of the configuration parameters must be carried out by qualified personnel In any case the risks from an incorrect setting do not constitute a danger for the patient The device is supplied with an internal lithium battery used to back up the RAM the average battery life is approximately 10 years If this message appears WARNING Replace the internal lithium battery Contact a service centre or the manufacturer for battery replacement 4 1 CLEANING THE DEVICE Clean the device with a damp cloth Make sure to dry it afterwards WARNING A 4 2 CLEANING THE REUSABLE TURBINE The turbine utilized with spirolab ZI 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 tu
39. e back of the device Do not use the power supply if it is wet or damp Green LED Orange LED Green LED POWER ON Battery charging Battery charged The charging process has several phrases which are indicated by two LEDs green and orange as shown above e Immediately after connecting the power supply the orange LED starts to flash e After a few seconds the orange LED stops flashing and remains lit e For about 10 minutes the charging is partial while device automatically checks the battery condition e After about 10 minutes the charging starts and proceeds to a full charge e When charging is completed the orange LED turns off and the green LED lights up WARNING A It is possible that during battery charging there may be a slight increase of a few degrees in the temperature of the power supply Always place the device on a suitable rigid horizontal on a stable surface with at least 30 cm 6 in of space all around the device The ventilation slots must be free from any cover or obstruction of any kind they are located both behind and underneath the plastic outer casing of the device 2 4 SWITCHING ON THE SPIROMETER First check that all the accessory items are in good condition spirolab III User Manual Code MIR 980067 REV 1 6 Page 28 77 Before using the device proceed with the cleaning operations as described in the MAINTENANCE AND CLEANING section Lift the LCD O release the catch Press the red on
40. ecution Possible warning message EX To end test press To print data see Paragraph 3 1 2 see example of the test printout report attached to this Manual 2 10 2 Sleep Oximetry To chose this test press 2 on numeric key This test records the variations in the patient s parameters overnight After approximately 5 minutes spirolab JIT will go to standby i e it stops beeping and the display turns off The led signal remains on To control the correct functioning while on standby press after 5 minutes spirolab JII will automatically return to standby If there is no signal while on standby the device will automatically exit this phase and a warning message will appear sensor unplugged or finger not detected correctly The data shown are the same as described in the preceding test except for information on this present phase which is not envisaged for this test The data shown are the same described previously After the required time the test can be interrupted as previously described Results can be printed as described in Paragraphs 2 13 and 3 1 2 see example of the test printout report attached to this Manual 2 10 3 Exsercise oximetry This test is made up of 3 phases e Baseline initial rest e Exercise e Recovery Baseline initial rest The data shown are the same described previously The duration of the test is minimum 2 minutes then this message appears pass to EXERCISE phase press 1 to pass to the f
41. erature and pressure BTPS stands for Body Temperature and Pressure Saturated which represents a world standard reference condition for the measurement of spirometric parameters All spirometric parameters are calculated at body temperature 37 C and pressure saturated In line with the publication STANDARDISED LUNG FUNCTION TESTING of the European Respiratory Society Vol 6 Supplement 16 March 1993 the air expired from the mouth is at a temperature of circa 33 34 C The expired flow and volume to be converted back to BTPS conditions 37 C must be increased by 2 6 this is derived from the BTPS factor of 1 026 at a temperature of 33 C which represents a correction of 2 6 In practice the BTPS factor for the expired flow and volumes is therefore constant and equal to 1 026 For the inspired volumes and flows the BTPS factor depends instead upon the ambient temperature as the inspired air is at ambient temperature For instance at an ambient temperature of 20 C with relative humidity at 50 the BTPS factor is 1 102 a correction of 10 2 spirolab III User Manual Code MIR 980067 REV 1 6 Page 34 77 he correction of the inspired volumes and flows is made automatically as the device has an internal temperature sensor all parameters are thus reported ati BTPS To make the calibration 1 Insert the volume in cL of the calibration syringe in use e g for a 3L syringe insert 300 cL 2 Inser
42. figuration menu with the device switched on press which contains the following list 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 Oximetry settings Incentive Turbine type Standard Date format Units format Auto power off Select the required option using 4 or V until the gt symbol on the left of the screen is alongside your selection then press to access the option NENI Use this key to recall the Configuration Menu to set up and or to change certain main functions of the device spirolab III User Manual Code MIR 980067 REV 1 6 Page 32 77 Delete data in memory To delete all the data in memory DELETE DATA IN MEMORY The display will show WARNING ALL SPIROMETRY TESTS IN MEMORY WILL BE DELETED E Use LJ to quit without deleting the test data TO PROCEED INSERT PASSWORD The password is 122333 After deleting the data in memory the display shows If the password is entered incorrectly the Test data has been DELETED display shows Available memory is 10096 PRESS ANY KEY TO EXIT PASSWORD INCORRECT ENTER to Retry Press 77 to repeat the procedure Print last calibration To print the turbine calibration coefficient currently in use plus the date of the last calibration made Turbine calibration WARNING A The turbi
43. for ensuring that the device is stored and used in appropriate environmental conditions in this regard reference is made to the specifics described in paragraph 1 5 below WARNING 1 1 4 Who can or must make the installation The device requires installation by qualified personnel The user shall normally configure the device accordingly 1 1 5 Subject effect on the use of the device A spirometry test should only be carried out when the subject is at rest and in good health and thus in a suitable condition for the test A spirometry test requires the collaboration of the subject since the subject must make a complete forced expiration in order to have a meaningful test result 1 1 6 Limitations of use Contraindications An analysis of the results of a spirometry test is not by itself sufficient to make a correct diagnosis of the subject s clinical condition Test comments a test interpretation and suggested courses of treatment must be given by a doctor Any symptoms that the subject has at the time must be carefully considered before a spirometry test is made The user is responsible to assess both the mental and the physical capacity of the subject to make a correct test and the user must also assess the degree of collaboration for each test carried out A correct spirometry test requires the complete collaboration of the subject The results depend on the person s capability to inspire and to expire all air completely and as fast as
44. ge Do not enn to sterilize the sensor Unplug the sensor from Spirolablll before cleaning or disinfecting to prevent damaging the sensor or the device and to prevent safety hazards for the user Do not use the instrument in the presence of magnetic resonance imaging MRI equipment MRI equipment may cause an induced current to the oximetry sensor resulting in patient injury a I M w H oc c Optical cross talk can occur when two or more sensors are placed in san 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 Errors in measurement or in interpretation can also be caused by spirolab III User Manual Code MIR 980067 REV 1 6 Page 14 77 e use by non qualified or non trained personnel lacking ability or experience e user error e use ofthe instrument outside the guidelines described in this User s Manual e use of the instrument even when some operational anomalies are encountered e non authorised servicing of the instrument e improper incorrect and or unreasonable use of the product WARNING A Following the European Directive 93 42 EEC for MEDICAL
45. he electrical information on the label of the charging unit corresponds to those of the electrical wiring of the mains supply In case the plug of the charging unit supplied with the device is not compatible with the electric socket of the mains supply contact qualified personnel for the substitution of the plug with a suitable one Generally it is not advisable to use adapters and or extension cables If it is essential to use them then only those conform to the safety standards must be used paying WARNING that they tolerate the maximum limits which are indicated on adapters and extension cables Unplug the power supply cable when battery charging is not required Do not leave the device attached to the mains supply when not required In case of breakdown or damage of the charging unit replace it only with the manufacturer s original spare parts use only original accessories and spare parts spirolab III User Manual Code MIR 980067 REV 1 6 Page 10 77 use of an unsuitable power supply may change the performance of the device and no longer guarantee the safety conditions In order to avoid dangerous overheating we recommend to totally unwind the power supply cable of the charging unit The maintenance operations detailed in this manual must be carried out precisely If these instructions are not followed this can cause measurement errors and or incorrect test interpretation Before doing any cleaning and or maintenance ope
46. he last volume cycle At the end of any test the related curves and the main measured parameters are shown After viewing the curves press 4 to view the remaining test parameters plus the predicted values and the percentage ratio between the measured value and the predicted value During the test the volume time curve is displayed 2 6 2 Spirometry post drug WARNING A To carry out a POST test it is necessary to have carried out at least one PRE FVC type test on the patient on the same day it is not possible to do a POST test on the PRE VC or MVV tests it is however possible to do a POST VC or MVV test if the archive already contains at least one PRE test carried out on the same day 1 case current patient data To perform a POST test on the current subject after completing e PRE test follow these instructions Pos Press sr to activate the POST phase On the bottom of display it is shown the following message ENTER to make POST test It is possible to carry out the POST test using one of the three tests available Selected the test in the lower part of display it is possible to define the dose administer to the patient before the test the value can be inserted with numeric keys spirolab III User Manual Code MIR 980067 REV 1 6 Page 44 77 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
47. his device must accept any interference received including interference that may cause undesired operation Any modifications not expressly approved by this company could void the user s authority to operate the device NOTE This device has been tested and found to comply with the limits for a Class B digital device pursuant to Part 15 of the FCC Rules These limits are designed to spirolab III User Manual Code MIR 980067 REV 1 6 Page 16 77 provide reasonable protection against harmful interference in a pee installation This equipment generates uses and can radiate radio frequency energy and if not installed and used in accordance with the instructions may Fone harmful interference to radio communications d However there is no guarantee that interference will not occur in a particular installation If this equipment does cause harmful interference to radio or television reception which can be determined by turning the equipment off and on the user is encouraged to try to correct the interference by one or more of the following posue e Re orient or relocate the receiving antenna e Increase the distance between the equipment and receiver e Connect the equipment to a wall socket which is on a different circuit from that to which the receiver is connected Consult the dealer or an experienced radio TV technician for assistance 1 5 TECHICAL FEATURES OF THE SPIROMETER Memory capacity for over 6000
48. ion 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 The use of an anti bacterial filter is at the discretion of the doctor If a single patient disposable turbine is used then a new one must be used for each patient 1 2 2 Turbine WARNING A spirolab III User Manual Code MIR 980067 REV 1 6 Page 11 77 it you are going to perform the spirometry test with a disposable i nt turbine it is of vital importance to use a new turbine for each PY patient The characteristics accuracy and the hygiene of mel 4 disposable turbine can only be guaranteed if it has been conserved beforehand in its original sealed packaging The disposable turbine Disposable is made of plastic and its disposal after use must adhere to the Turbine local regulations and norms in force The correct functioning of the re usable turbine can only bell guaranteed if it has been cleaned in the correct manner and is free from foreign bodies which could restrict its movement If the turbine has not been cleaned sufficiently this could cause cross contamination from one patient to anothe
49. l solution in place of a drug to examine the subject s response to such a stimulus If the subject is healthy then the reaction to a placebo is almost zero but in the case of hypersensitivity even this stimulus can have some effect In the physiological test the amount of the dose to enter is zero and it is still possible to compare the POST results with those of the PRE test The POST phase will show a coloured string highlighting the words POST FILE No and DOSE WARNING A he POST test can be based only on a PRE test made in the same day it is not possible make a POST test referred to a PRE test made in the previous days WARNING A p To end the POST phase and make new PRE tests press and then 2 7 TEST QUALITY CONTROL SPIROMETRY spirolab III User Manual Code MIR 980067 REV 1 6 Page 46 77 Through a mathematical analysis quality control which is applied to certain calculated indices and parameters the spirolab ZII produces a series of comments helpful for understanding the reliability of the test made ERROR IN Vext and PEFT If the extrapolated volume Vext is greater than 500 mL or more than 596 of the FVC or if the PEFT time to peak flow is greater than 200 ms this message is shown Repeat test and blow faster FLOW DROP 50 If the flow rate falls 25096 and then rises again during the 1 second of a forced expiry this message is shown Repeat and avoid coughing FET ERROR If the FET is less than the
50. maximise the signal strength WARNING A in order not to compromise the reproducibility of the measurements and the integrity of the sensor avoid twisting the sensor cable and handle with due care when using connecting disconnecting and when placing the finger into it During the first few seconds of the test the device searches for the best signal after which the timer re sets to zero and spirolab J 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 Connect sensor Contemporaneously spirolab ZII emits a beep for 10 seconds If the sensor has been inserted but the finger is not inserted correctly the following message will appear Insert fingher Contemporaneously spirolab ZII emits a beep for 10 seconds spirolab III User Manual Code MIR 980067 REV 1 6 Page 51 77 If the sensor correctly receives the signal after a few seconds the device starts to beep and the values will be displayed on the screen For all oximtery tests alarms can be set up in the case that the critical values are exceeded as described in paragraph 2 5 5 In the case that the alarm is activated during the test the symbol on the display will be seen and this can be activated disactivated by pressing to disactivate and p to activate For further information on the correct set up for this function please refer to paragraph 2 5 5 2 10 1 S
51. mmended separation distances between portable and mobile RF communications equipment and the Spirloab Il 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 JI can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the spirolab JM as recommended below according to the maximum output power of the communications equipment Separation distance according to frequency of transmitter Rated maximum m output 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz power of transmitter d 3 5 VP 4325 VP 4 _Z VP V E E W 0 01 0 12 0 24 0 24 0 1 0 37 0 37 0 74 1 1 17 1 17 2 34 10 5 28 5 28 1 056 100 11 66 11 66 23 32 For transmitters rated at a maximum output power not listed above the recommended separation distance din metres m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people spirolab
52. mn headed CHG In the POST phase the measured result is compared to the values of the related PRE test The Flow Volume curves of the PRE test and related POST test are shown superimposed After the two curves the measured parameters POST the related PRE values and the percentage variations between POST and PRE are also shown To make the results shown easier to understand a traffic light system has been used with the following icons and or as per the criteria below significant broncodilatation with FEV1 POST 2 80 of predicted ORG significant broncodilatation with FEV1 POST lt 80 of predicted OR no significant broncodilatation WARNING A spirolab III User Manual Code MIR 980067 REV 1 6 Page 45 77 are shown in the POST phase no test interpretation is given the test quality control messages The POST test is available both T shit WOM with the characteristics of the patient and in FILE visualization of previous test or Lm in this manner is easy to set post phase Visualizing the data 1O the active keys are AY e ID for a new spirometric test with patient selected Pos for a POST test 8 print out of the selected test E and KE for display to go to the archivi menu e Le key for generic stop e 1 2 3 if there are made more than one test Physiological test placebo It is common practise prior to a POST test to carry out a test using physiologica
53. mpatible mouthpiece to avoid any problems to the patient unsuitable materials could cause a bad functioning of the instrument and therefore the test fl results could be incorrect The user is responsible for obtaining the correct type of mouthpieces for the device Those required are a standard type with an outside diameter of 30 mm they are commonly used and in general easily procured WARNING To avoid environmental contamination caused by the disposal of used mouthpieces the user must adhere to all relevant local regulations l 1 2 4 Oximetry sensor The following oximetry sensors can be used with spirolab III adult sensor reusable Comfort Clip These sensors require the use of an extension cable cod 919100 to be correctly connected to the device The same sensors are also available with microconnector for the direct connection Prolonged use and or the patient s condition may require changing of the sensor site periodically Change sensor site and check skin integrity circulatory status and correct alignment at least every 4 hours WARNING A Incorrectly applied sensors or damaged cables may cause inaccurate readings Using a damaged sensor may cause inaccurate readings possibly resulting in patient injury or death Inspect each sensor before use If a sensor appears damaged then do not use it Use another sensor or contact your authorized repair centre for assistance Use only MIR sensors supplied with
54. n the European Standard EN 60601 1 2 spirolab IIT 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 After removing the device from its packaging check that there is no visible damage In case of damage do not use the device and return it to the manufacturer for repair WARNING A re safety and the correct performance of the device can only be assured if ve user of the device respects all of the relevant safety rules and regulations The manufacturer cannot be held responsible for damage caused by the failure of the user to follow these instructions correctly In the event of any incident or accident of any kind resulting from the use of the device the user is required to inform the manufacturer without delay this procedure is laid down in article 9 of the European Regulations No 46 1997 which confirmed the CE Directive No 93 42 Safety and correct functioning of the device are guaranteed only if the safety standards in force are respected TEEEUNCEDCEUEIUMGOUORUR GNI OO OO RU EO OE E spirolab ZII User Manual Code MIR 980067 REV 1 6 Page 8 77 keep the instructions for use together with the warranty conditions for any future reference or in case the device presents technical problems The manufacturer cannot be held responsible for damage caused by the failure al the use
55. nd press e itis 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 e when the request is from mobile phone type the code shown on the screen relative to the device s Serial Number reported on the back label of spirolab ZI e are executed all the next connection steps e When the connection is active data are transmitted from the selected modem e Atthe end of the transfer data process the following message Connection Completed is shown qu The screen will show the following information e The device used for the connection spirolab III User Manual Code MIR 980067 REV 1 6 Page 60 77 e The pre set phone number e The preset PIN corresponding to the serial number of the device EX To interrupt data transmission during the Bluetooth connection press to end the connection and to return to the main screen Where no device has been setup for data transmission a message will appear on the display to start searching for enabled devices After setting the device the connection will start up automatically 3 1 4 Data Transmission via Bluetooth for printing WARNING A Printing of data from the patient management function is enabled only if the printer has a Bluetooth connection alternatively a USB key can be installed on the printer Jin order to enable a Bluetooth connection The Bluetoo
56. ne flow sensor does not require calibration but needs only regular cleaning If a calibration must be made then the following guidelines must be carefully noted Only the reusable turbine can be calibrated NOTE spirolab III User Manual Code MIR 980067 REV 1 6 Page 33 77 Each time a calibration is made the new correction factor is algebraically added tol the previous correction factors Therefore before making a new calibration make ff sure to delete the actual calibration in use as described above For an accurate and reliable calibration the syringe volume must be at least 3 L 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 From configuration menu choosing turbine calibration on the display appears the following informations SYRINGE VOLUME cL 300 OLD CALIBRATION BTPS FVC 300 FIVC 300 NEW CALIBRATION ATP ERR 0 0 The values last FVC and last FIVC are retailed to AUS the last calibration The values under the ERR Five column indicate the actual correction They are set ERR TOTAL ERROR on 0 for default BTPS Measure condition ATP Conversion from BTPS If FVC and FIVC 0 then use factory calibration WARNING A ATP stands for Ambient Temperature and Pressure which indicates that the measurement conditions are ambient temp
57. nsor esssseseeneeeeneenenenn eene 28 2 5 4 Switching off the spirometer seeeeeeeeeeeneneeenennnem nnns 28 2 5 5 Iritial settlngs rre REPeERUESERUD E REI ERES 29 2 5 6 Functioning of the spirometer ssseeen n 35 2 5 7 New subject data entry cccccesecceeessececeeeeeseneeeesenseseneeseeeeseesenenenseneenenenees 37 2 5 8 Modify subject data 2 ce aient tertius 38 2 6 Spirometry fvc VC IVC MYV ssssssssssssesssseseeeeeee enne enne nennen nennen 38 2 6 1 Spirometry testing eriei inea c ere PEL roc ten t E 39 2 6 2 Spirometry post dig aceite ep LO etr re EE e Rie PRRRE DS aa RT 40 2 7 Test quality control spirometry ssssemm enne 42 2 8 Repeatability of the fve test 2 0 ceeeceeeseneceeeeeseeeeeeeeaeeeseseeeeeesseeeneeeeseeesesenseeessones 43 2 9 Method of measurement and interpretation ees een 43 2 10 Oximetry testihg 2 oec ciere Crece toe ee dle e tto dote e DL ee ele d agere 44 2 10 1 SpoLOXImelly iut one ete t tt hain negra 47 2 10 2 Sleep Oximetry sec aee E d la dies 48 2 10 3 Exsercise Oximeltry enit eet RO I Rent niania nii 49 2 10 4 Spot oximetry MEMORIZED LIKE OXYTEST seen 50 2 11 File organization iie P EHE AGE RERO 50 spirolab ZII User Manual Code MIR 980067 REV 1 6 Page 4 77 2 12 Search and read tests in memory
58. o the ATS standards generates a series of messages which correspond to possible levels of obstruction or restriction plus one level of normal spirometry as shown in the following table normal gt green mild gt green yellow moderate gt yellow moderately severe gt yellow red severe gt red very severe gt violet If it is not possible to make the calculations for lack of data the interpretation is not valid and this message appears NOT VALID WARNING A spirolab III User Manual Code MIR 980067 REV 1 6 Page 48 77 test results made by that subject he interpretation during a test session for each subject always refers to the besti 2 10 OXIMETRY TESTING spirolab JJ can carry out different types of oximetry tests which are described in the following paragraphs WARNING If spirolab JIT has been purchased without the oximetry option then only spirometry tests can be made If the oximetry option is purchased afterwards then contact the service centre or the manufacturer to enable the function If during the oximetry testing the SpO2 blood pulse rate goes below the lower threshold or goes over the upper threshold spirolab ZII will beep while this situation persists This option can be switched off during sleep tests The values shown are the default settings WARNING A Note the sensor described below is for illustration purposes only spirolab ZII is enabled for the use of any of the sensors desc
59. off key on the upper left corner of the keyboard When the device is on the green led on the right hand side of the on off key will light up WARNING A When the device is connected to a PC via a USB cable then it will automatically ll power on as the power supply is internal 2 5 SETTINGS Backlight settings To adjust the brightness of the display back light use the double key Press several times as required on the left to diminish the brightness or on the right to increase it 2 5 4 Contrast settings To adjust the display contrast to account for the angle of vision and the surrounding lighting use the double key Press several times as required on the left to diminish the contrast or on the right to increase it 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 WARNING A The thermal paper must be inserted as shown in this picture paying WARNING to the position of the paper holder roll pins inside the guides and to the direction of the roll so that printing occurs on the correct side of the thermal paper Note that the thermal paper cannot be printed on both sides but only on the one face up of the paper roll spirolab III User Manual Code MIR 980067 REV 1 6 Page 29 77 Guide to the correct positioning of the paper roll holder Push the paper into the slot loca
60. ollowing phase If the phase lasts for more than 6 minutes then spirolab III will emit a beep as a reminder to pass to the exercise phase Exercise Phase At the beginning of this phase the timer is reset to zero to give an accurate control of the duration of each single phase The data on the display is the same as shown before spirolab III User Manual Code MIR 980067 REV 1 6 Page 54 77 The duration of this phase is minimum 2 minutes this message will appear pass to RECOVERY phase press 2 for a few seconds to pass to the recovery phase If this phase lasts for more than 6 minutes then spirolab J will emit a beep after which the device passes to the initial phase and the timer is re set to zero Recovery Phase The user can decide freely on the duration of this phase the duration is not suggested at the beginning of the phase the timer re sets to zero EX To end test press At the end of the test the data required for the calculation of the parameters must be inserted more specifically Baseline DYSPNEA SEVERITY Final DYSPNEA Baseline FATIGUE Final FATIGUE These follow the Borg scale and ca have the following values 0 0 5 1 2 3 4 5 6 7 8 9 10 The Borg scale coefficients represent the following severity values Use KI and p to enter data use V or to go back or pass to next data Exercise test data results are given in the following screen and can be printed as des
61. or specifically intended for use with the spirolab ZII Use of other types of sensors may cause inaccurate readings spirolab III User Manual Code MIR 980067 REV 1 6 Page 13 77 oximetry measurements may be inaccurate in the presence of high ambient light l Shield the sensor area with a surgical towel for example if necessary WARNING A Dyes introduced into the bloodstream such as methylene blue indocyanine green ll indigo carmine patent blue V PBV and fluorescein may adversely affect the accuracy of the oximetry reading Any condition that restricts blood flow such as the use of a blood pressure cuff or a device for systemic vascular resistance may cause an inability to determine aes pulse rate and SpO2 readings Remove fingernail polish and or false fingernails before applying SpO2 sensors Both may cause inaccurate oximetry measurement Significant levels of dysfunctional hemoglobins such as carboxyhemoglobin or methemoglobin may adversely affect the accuracy of the oximetry measurement proximity Optical cross talk may adversely affect the accuracy of the oximetry readings The danger can be eliminated by covering each site with opaque material Obstructions or dirt on the sensor s emitter and or detector may cause a sensor failure or inaccurate readings Make sure there are no obstructions and that the sensor is clean Autoclaving and or ethylene oxide sterilizing may cause sensor dama
62. ortex in the passing air around the axis of the sensor A rotor with a speed of rotation directly proportional to the air flow then interrupts the infrared beams and generates a digital signal The measurement of the air volume that passes through the tube is proportional to the interruption of the infrared rays This measurement principle guarantees stability reproducibility and reliability over a long period of time and the measurement is not affected by gas density humidity or pressure WARNING A The measurement of the air volume that passes through the tube is proportional to the interruption of the infrared rays The cleaning of the turbine flow sensor is very simple and is essential for the protection of the subject from possible infections For cleaning operations see Chapter 4 of this Manual No calibration of the turbine is required but it is good practice to make a calibration check by following the simple instructions contained in the relevant paragraph in the maintenance section of this manual Method of test interpretation Following each FVC test the device carries out a quality control check to verify the acceptability of the test made and if possible compares the main measured parameters FEV1 FEV1 and FVC with the respective predicted values It also calculates a series of indices based on the following criteria index measured values x100 predicted values The interpretation of these indices according t
63. ound for 10 seconds e If the test has been interrupted due to low battery power an intermittent beeping will be heard for 10 seconds when the device is switched on again The specifications for both the oximetry and for the cardiac pulse are the same regardless of which of the above mentioned oximetry sensors is used 2 PRODUCT DESCRIPTION Spirolab II is a spirometer with an optional pulse oximetry module that facilitates the total valuation of lung function It is a powerful and compact measurement device intended for use by a physician respiratory specialist and which is capable of calculating more than 30 spirometric parameters Spirolab7II is able to make FVC VC IVC MVV and breathing profile tests as well as the saturation of oxygen in the blood and the heart beat It can operate in stand alone mode and it can be connected to a PC or to a printer using any one of several available methods RS232 USB Bluetooth It calculates an index of test acceptability test quality control and a measure of reproducibility It also gives functional interpretation with 11 possible levels following the latest ATS American Thoracic Society classification it has an internal memory sufficient for over 6000 spirometry tests or for 1000 hours or 40 days of oximetry monitoring spirolab III User Manual Code MIR 980067 REV 1 6 Page 23 77 The main spirometric parameters are measured and displayed and all data with Flow Volume and Volume time
64. pot oximetry WARNING A The sensor described below is for illustration purposes only spirolab JI is enabled l lfor the use of any of the sensors described in 1 2 4 MIR does not recommend the ff use of a specific type of senor any decision in made by the individual doctor To perform a non invasive continuous monitoring of arterial oxygen saturation it is recommended to use the reusable wrap sensor The use of this sensor is indicated for patients weighing more than 30 Kg and contraindicated for patients with allergy to adhesive tape WARNING A The materials used for manufacturing the sensor are NATURAL LATEX PROTEIN free The materials used for the sensor are subject to biocompatibility tests Adult Single Patient Sensor Instructions for Use WARNING A This sensor is contraindicated for use on patients who exhibit allergic reactions to the adhesive tape Do not reuse One use on one patient e Choose an application site on the patient s finger or toe where the light source will be directly over and in line with the detector The preferred sites are the forefinger or smaller thumb e Remove nail polish or artificial fingernails spirolab III User Manual Code MIR 980067 REV 1 6 Page 52 77 e Place the patient s digit in the sensor nail side up lining up the digits pad over the detector The sensor s positioning line runs across the mid axis of the fingertip e Wrap the bottom adhesive around
65. r Periodic cleaning should only be done when the instrument is for personal use and Pens will only be used by one patient The cleaning of the turbine should urine be performed according to the instructions contained in the User s Manual X For cleaning operations see MAINTENANCE AND CLEANING in this Manual The following information applies to both types of turbine The turbine must never be held under a jet of water or air and must never come into contact with high temperature fluids 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 3 Mouthpiece Any disposable mouthpieces included with the device are supplied only as a guide to the correct type and dimensions of the mouthpiece required for this device they are clean but not sterile To purchase appropriate mouthpieces generally either paper or plastic but in any case mono use disposable we suggest that you contact your local distributor who supplied the spirometer WARNING A spirolab III User Manual Code MIR 980067 REV 1 6 Page 12 77 use a bio co
66. r to follow these instructions correctly misuse of the device whether that ff misuse is improper incorrect and or unreasonable or when the device is connected to an electrical outlet which does not conform to the safety regulations in force The device and its accessories must be controlled before each and every use so that any malfunction and or damage caused during transport and or storage may bell detected Keep the device away from hot and or cold sources The thermal paper used for printing is highly inflammable Keep away from open f flames may interfere with the correct functioning of the device High frequency emissions coming from other electrical or electronic devices can interfere with the functioning of the device For this reason certain minimum clearances a few meters should Ibe observed when high frequency appliances such as TV radio cellular phones etc and other electronic units are operated in the same room When connecting the spirolab ZII to any other devices PC printer modem etc the user must guarantee that the required security level for subjects and or users in the same room are not in any way endangered by the connection If the PC and or the printer connected to spirobank ZI come into contact with the area containing patient data ref directive EN 60601 1 1 it is necessary that they conform to the directive EN 60601 1 The instrument may give inaccurate readings if operated in the presence of st
67. r to initiating the following procedure it is important to know the version of the operating system on the PC from Control Panel click on System and here the operating system installed on the PC can be checked To make the connection insert the mini USB connector supplied with spirolab ZII as shown in the picture and attach the other connector to the USB port of the PC When initally making a connection the PC will depending on the version of the operating System either make an automatic driver installation or request some information To avoid errors in this phase please read the winspiroPRO User Manual very carefully 3 2 2 Connection to PC through RS 232 port spirolab III can be connected to a PC through a RS 232 serial port This leaves the USB port free The picture shows the RS 232 connector attached to spirolab III For the correct management of the device see the software manual 3 3 UPGRADE INTERNAL SOFTWARE spirolab ZII can be upgraded when connected to a PC via USB or RS232 Upgrades can be downloaded by registering on www spirometry com For further information on upgrading software see the winspiroPRO software manual 4 MAINTENANCE AND CLEANING spirolab III is an instrument that requires very limited maintenance The operations to perform periodically are e Cleaning and controlling of the reusable turbine e Changing the disposable turbine at each test spirolab III User Manual Co
68. rations always switch off the device and unplug the power supply Keep the device out of reach of children and of any person with mental handicap When deciding to no longer use the device it is recommended to dispose of it according to the local regulations In order to avoid contamination of the environment provoked by disposing of the spirometer of its accessories of plastic consumable materials or parts follow all local regulations Device lithium backup battery life is 10 years Do not use the device beyond the extimated life advised by the manufacturer Hs lithium battery is continuously monitored by the device if the battery is discharged a warning message indicates that it must be replaced Contact an lauthorised Service centre to change the battery If the LED of the lithium back up battery flashes the test data and spirometry parameters in the memory plus the device configuration then all information stored may be cancelled automatically The batteries used for power supply and for data storage are both inside the device It is not permitted to open the device in order to replace them This procedure must be carried out only in an authorised service centre authorized by the manufacturer The maintenance operations detailed in this manual must be carried out to the letter If these instructions are not followed this can cause measurement errors and or an incorrect test interpretation 1 2 1 Danger of cross contaminat
69. rbine Cleaning of the disposable turbine is not required as it is supplied already clean in a sealed plastic bag It must be disposed of after use The maintenance operations to perform are cleaning and controlling of the turbine spirolab III User Manual Code MIR 980067 REV 1 6 Page 63 77 WARNING A is good practice to control from time to time that dirt or foreign bodies such as threads or hair are not deposited inside the e ra Any such deposit could SJ or block the blade of the turbine and thus compromise the measurement accuracy u To clean the reusable turbine remove it from its compartment in the MiniFlowmeter by turning it anti clockwise and pressing lightly It can be helpful to push it gently from underneath with one finger Miniflowmeter Turbine Mouthpiece Immerse the turbine in a cold detergent solution and move it within the liquid to remove any impurities which may be deposited inside Leave the turbine immersed for the time specified in the instructions of the solution WARNING A To avoid causing irreparable damage never clean the turbine by placing it under all direct jet of water or any other liquid Where no cleaning solutions are available it is indispensable to clean the turbine in clean water Do not sterilize in an autoclave This operation would cause irreparable damage to the turbine Rinse the turbine by immerging it in clean water not hot
70. required Recall a subject from memory and press the ID key to create a new test session with the anthropometric details of the same subject This avoids having to reinsert all of the data of that patient If the ID code inserted already exists in memory then the following message appears WARNING ZID ALREADY ASSIGNED CONFIRM ID CODE OR MODIFY The user may either exit enter a new ID code or continue by using the patient file in memory Press to confirm the code press one of the arrow key to modify DATE OF BIRTH Insert patient data with the numeric keys spirolab ZII automatically calculates the patient age which is then shown in the space AGE Insert the other data using HEIGHT Enter the subject s height in cm or in inches according to the current configuration using the numeric keyboard Go to next entry using 7 WEIGHT spirolab III User Manual Code MIR 980067 REV 1 6 Page 41 77 Enter the subject s weight in Kg or Pounds according to the current configuration using the numeric keyboard Go to next entry using SEX Select gender using the keyboard Elo male and o female ETHNIC GROUP A list of possible ethnic groups appear enter the number corresponding to the required ethnical group Press 0 for no conversion factor By matching a subject to an ethnic group the predicted values for that subject are then modified by a percentage determined by the ERS and published in THE EUROPEAN RESPIR
71. ribed in the previous Paragraph 1 2 4 MIR does not recommend the use of a specific type of senor this decision is made by the doctor During the oximetry test spirolab ZII cannot be switched off to switch off the device it is necessary to interrupt the test in progress this avoids unwanted interruptions which could compromise the accuracy of the data obtained For the non invasive measurement of the SpO2oxygen saturation and blood pulse rate utilize the re usable finger sensor This sensor is recommended for patients weighing 20 Kg with limited activity spirolab JIT memorises the two oximetry values every 2 or 4 seconds Carry out an oximetry test as follows spirolab III User Manual Code MIR 980067 REV 1 6 Page 49 77 Connect the sensor to the instrument insert the connector with the arrow printed on the connector face up as shown e Choose a high perfusion site which is easily adaptable to the sensor e Insert finger into the sensor until the finger touches the end of the probe Ensure that the bottom part of the finger completely covers the detector If the finger is not able to be correctly positioned use another finger e Position the sensor so that the cable is underneath the palm of the hand This enables the light source to remain on the fingernail and the detector on the bottom part of the finger From the main screen Spo press to access the test menu e Select required test using the vertic
72. rmation contained in this User s Manual as required Any suggestions and or comments regarding this product should be sent via email to mir spirometry com Thank you MIR accepts no responsibility for any loss or damage caused by the use of the device due to the use of this Manual and or due to an incorrect use of the product Note that due to printing limitations the screenshots shown in this manual may differ from the display of the machine and or from the keyboard graphics Copying this manual in whole or in part is strictly forbidden IMPORTANT NOTE If the instrument is returned for repair it must be accompanied by a clear and detailed explanation of the defect or problem found e theunit must be returned in its original packaging e transport costs must be prepaid Manufacturer s address MIR srl Via Del Maggiolino 125 00155 Roma Italy Tel 39 0622754777 Fax 39 0622754785 e mail mir spirometry com spirolab ZII User Manual Code MIR 980067 REV 1 6 Page 3 77 INDEX INTRODUCTION vests Ete he Ten e b e ed deae iege e oe Pe DR CE 6 1 GENERAL INFORMAT ION 3 225 838 reete te er heel Gages pede dE erate 6 1 1 Intended se ee e e dre en e ee ree eret 6 1 1 1 User Category 3 oii eie debe UR REAR RIEN EDS 6 1 1 2 Ability and experience required seem e 6 1 1 3 Operating environment nennen nnne nennen nennen 7 1 1 4 Who can or must make the installation eee 7 1
73. rong electromagnetic sources such as electrosurgical equipment or in the presence of computed tomography CT equipment If the device is not functioning properly switch it off and consult the instruction manual After correctly following all the instructions if the device does not function correctly call the manufacturer or an authorized service centre for assistance Ian frequency emissions that are outside the limits expressed by the EN60601 1 2 For any repairs call only certified service centres that are authorized by the manufacturer or directly call the manufacturer Do not open or tamper with the device Always use and demand only original spare parts For the recycling of the Spirolablll the accessories plastic consumable materials mouthpieces and removable parts for example the disposable turbine use only the appropriate containers or return all such parts to the dealer or to a recycling centre All applicable local regulations must be followed If any of these rules are not followed then MIR will decline all responsibility for any direct or indirect damages however caused spirolab ZII User Manual Code MIR 980067 REV 1 6 Page 9 77 use of non original parts such as the turbine flow sensor and other accessories may cause errors in measurement and or compromise the correct functioning off I device and is therefore not permitted The installation must be carried out according to the manufacturer s ins
74. s of the turbine remain unaltered over time e For the disposable turbine must always be substituted between patients e For the reusable turbine always clean the turbine between patients to ensure the maximum level of hygiene and safety for the patient For a correct interpretation of a spirometry test the measured values must be compared either with the so called normal or predicted values which are calculated from the anthropometric details of the patient or alternatively with the personal best values from the clinical history of the subject The personal best values can vary considerably from the predicted values which are taken from healthy subjects spirolab III User Manual Code MIR 980067 REV 1 6 Page 24 77 Spirolab7II is supplied with an RS 232 optoisolated serial communication port which guarantees excellent electrical protection gt 4 KV both for the health care worker and for the subject in compliance with the most strict European safety standards EN 60601 1 The Bluetooth connection system can be used to connect the device directly to a printer the Bluetooth system must be installed and enabled on the printer as well Spirolab7II can also be connected to a PC or to another computerised system to configure the system All spirometric test results plus the related subject details stored inside the device can be transferred from the device to the PC and then viewed within the winspiroPRO PC software Flow
75. s the charging This thermo protector can intervene if e the device has operated beyond the functioning limits indicated in this manual e the device is operated near a heat source or in ambients with a temperature either too high or too low Disconnect the power supply and let it cool down before continuing with charging The lithium battery for the data memory indicates discharged If the internal lithium battery is discharged the spirometry parameters in the memory and other configuration data may be cancelled automatically Contact an authorized service centre to replace it The printer does not print The thermal paper may have run out otherwise may be inserted in the wrong way Check the correct position of the thermal paper if necessary insert a new roll of thermal paper The printer is in thermal protection The printer is also protected thermically In case the printer reaches elevated temperatures then a thermal protection intervenes and blocks the functioning of the printer A message on the display appears to signal the protection Let the printer cool down before turning on the device again The printer makes noises Make sure there is a sufficient quantity of thermal paper Make sure that the thermal paper and the thermal paper holder are positioned correctly Make sure that the thermal paper container lid is in the correct position The device does not measure spirolab III
76. screen 2 6 1 Spirometry testing Insert a new mouthpiece into the MiniFlowMeter mouthpiece holder Fit the nose clip onto the nose of the subject to ensure that air cannot escape through the nostrils The subject must insert the mouthpiece well into the mouth it should be inserted at least 2 cm beyond the front teeth and held between the teeth closing the lips to ensure that air cannot escape from the sides of the mouth Breathe as directed according to the test to be undertaken details follow Make the test in either a standing or a sitting position During total expiration slowly or forced lean forward to help the expiratory action with a compression of the abdomen FVC If required this part is optional before the test make several breaths at rest When ready inspire slowly as much air as possible opening the arms helps and then expire all of the air as fast as possible Then without removing the mouthpiece from the mouth finish the test by inspiring again as fast and as completely as possible This final inspiration is not necessary in the case that the inspiratory parameters FIVC FIV1 FIV1 PIF are not required The cycle can be repeated several times without removing the mouthpiece in which case Spirolab II will automatically select and show the best test and measured parameters To EX end test press or just wait for 3 seconds after the last volume cycle the test terminates automatically WARNING A In the
77. spirolab ZI User Manual User Manual Rev 1 6 Issued on 23 04 2007 spirolab ZII User Manual Code MIR 980067 REV 1 6 Page 1 77 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 CODE PRODUCT with oximetry CODE option option pirolab III device 910551 spirolab III device plus oxy 910551 USB connection cable MiniFlowmeter to Spirolab 7 532370 CD winspiroPRO _1 spare fuse internal 4A 1 spare fuse internal 4A 270468 _ OPTION OPTION Connection cable RS 232 9 pin for PC Before using your spirometer Please read this manual carefully plus the labels and all of the information supplied together with the product WARNING A A Note that this symbol means read the instructions carefully before use spirolab ZII User Manual Code MIR 980067 REV 1 6 Page 2 77 Set up the device date time language predicted values etc to your requirements as described under Configuration Menu in this Manual Keep the original packaging In the event that your spirometer has a problem always use the original packaging to return it to your local distributor or to the manufacturer MIR has a policy of continuous product development and improvement and me manufacturer therefore reserves the right to modify and to update the info
78. spirometric tests The precise number depends on the individual configuration so it cannot be determined more closely Memory Bi directional digital turbine Semiconductor 0 45 C Rechargeable battery Ni MH 6 elements 1 2V each 4000 mAh Output vonitage 12 V current 1 A compliant with EN 60601 1 Use exclusively battery charger provided spirolab III User Manual Code MIR 980067 REV 1 6 Page 17 77 Type of electrical protection _ Safety level for shock hazard lass Il device y inflammable anaesthetic gases or oxygen Apparatus not suitable Temperature MIN 20 C Conditions of storage MAX 60 C Temperature MIN 10 C MAX 40 Cc Electrical Safety Standard EN 60601 Applied norms Storing of parameters FlowVolume and Volume time curves The number of tests cannot be precisely defined as it depends on the set up made by the individual user Display spirolab III B W Graphic LCD passive type FSTN 320x240 Pixel spirolab III colour Graphic LCD 16 colour passive type FSTN 320x240 Pixel Keyboard Silicon rubber keyboard 07 Hardware function keys with symbols 15 Software function keys with symbols 05 Arrow keys with symbols right left up down enter 02 Gender identification with appropriate symbols 10 Number keys 29 International alphabet keys WARNING A 1 6 TECHNICAL SPECIFICATIONS 1 6 1 Features of
79. st saved on file after recalling it press Ss 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 There follow the Flow Volume and Volume time curves which relate to either the last or best test performed Press from the main screen to print the best test results of the day relative to the displayed patient To print the last test press while viewing the last test Lastly the measured parameters and spirometry test interpretation are shown In the case of a PRE test the following are shown Predicted calculated predicted values PRE measured value before drug administration Predicted values percentage value against predicted values In the case of a POST test then the graph will show the two curves superimposed and in addition to the above mentioned parameters the following values POST measured value after drug administration CHG variation between POST and PRE a EC SJ From the measured parameter s screen C or O or recalled from memory the subject s name date and time of test is shown on the bottom of the screen 3 DATA TRANSMISSION spirolab III includes a Bluetooth wireless data transmission system This connection is via radio and allows the transferring of all the data in memory for two different operations e transfer to
80. t both the FVC and FIVC values obtained by the measurement made with the calibration syringe in the New FVC and New FIVC field Use vertical scrolls to select the value to be modified SIRIN New FVC New FIVC Use numeric keys to modify the parameter value selected If the calculated correction factors are acceptable lt 20 they are displayed beside the New FVC and New FIVC parameters Press ESC to return to the configuration Menu without entering the correction If the FVC and FIVC values produce a correction factor that is gt 20 the FVC and FIVC values will not be accepted This means that the system cannot correct for such a large calibration error The following message appears WARNING ERROR too high In this case Check the correct functioning of the spirolab IJI with a new turbine and or Clean the turbine To erase the calibration in use and reset to the factory calibration input 0 in the New FVC and New FIVC fields Then press to return to the Configuration Menu WARNING A With the new calibration the correction factors are algebraically added to the previous correction factor s Before to begin a new calibration set the two values FVC and FIVC at 0 then repeat the calibration procedure If a 3L syringe is used to make the calibration and if the spirometer is calibrated correctly then the FVC syringe value will be 3 00 FVC x 1 026 BTPS 3 08 L FVC at BTPS If the ambient temperature
81. ted 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 The paper must advance through the slot in the compartment when it is closed close the lid of the compartment If necessary make the paper advance manually by pressing Md WARNING A To avoid damage to the printer and or defects in printing it is recommended to use thermal paper with 112 mm width size The sensibility of the thermal paper must be suitable for printers with a printing speed of 50 mm s This type of paper is easy to find at most medical device dealers spirolab III User Manual Code MIR 980067 REV 1 6 Page 30 77 2 5 3 Connecting the flow sensor The flow sensor is made up of the elements shown in the following illustration 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 spirolab ZM as shown in the image again the click will indicate the correct insertion Miniflowmeter Turbine Mouthpiece Make sure that a new disposable mouthpiece has been correctly inserted in the turbine mouthpiece holder WARNING Remove the used mouthpiece and dispose of it
82. th system enables spirolab III to transfer test data directly to a printer with Bluetooth The sequence of activities to be followed is e When the test is finished or searched in the archive press twice e spirolab ZM will carry out the phases of connection e At the end of the transmission spirolab IJI will show the message CONNECTION COMPLETED returning automatically to the main screen Previous tests stored on file can also be printed Use the procedure described in Paragraph 2 11 to print required tests When the required test is shown on the display press twice ESC To interrupt data transmission during Bluetooth connection press to end the connection and to return to the main screen Where no printer has been set up a message will appear to search for devices After the device has been set up it will automatically be enabled for printing When searching for Bluetooth enabled devices spirolab IZ will check the address of that device and where a previously registered device has changed name it will be automatically updated 3 2 CONNECTION TO APC spirolab ZII can be connected to a PC and perform tests online Two connection types are used USB port or RS 232 port spirolab III User Manual Code MIR 980067 REV 1 6 Page 61 77 3 2 1 Connection to a PC through a USB port WARNING A Before connecting spirolab JII to a PC via the USB port the winspiroPRO software must be installed to interface with the device Prio
83. the digit being careful not to cover the nail e Fold the sensor s top over the digit making sure the light source is directly over and in line with the detector Wrap the adhesive around the finger or toe to secure the sensor Route the cable along the palm or the bottom of the foot and secure with adhesive tape if necessary Connect the sensor to the instrument insert the connector with the arrow on the connector face up and control the correct functioning according to the previous instructions WARNING A Do not twist unnecessarily or use excessive force when using connecting disconnecting or storing the sensor An over tight sensor can produce inaccurate saturation measurements Therefore avoid over tightening the adhesive tape It is recommended to fasten the cable to the wrist with a bandage Making a Test Select Oximetry SpO2 BPM from the oximetry tests list pressing 1 on the numeric key The display shows Oximetry SpO2 BPM The test duration is unlimited and the aim is to record variations of the oximetry values during a period as decided by the doctor If the finger is removed from the sensor during the test the following message will appear Please wait for signal The data shown during the test are e Spo2 e Quality of signal received e BPM spirolab III User Manual Code MIR 980067 REV 1 6 Page 53 77 Test time extension Time curve of the two parameters SpO2 and BPM Test type in es
84. ticular WARNING on cleaning operations cross contamination risk all require qualified personnel WARNING A MIR cannot be held responsible for any damage caused by the user of the device failing to follow the instructions and warnings contained in this manual If the user of spirolab JI is a person considered to be cognitively impaired then the operation of the device must be made under the supervision and responsibility of whoever is legally charged with the supervision of this person spirolab ZII User Manual Code MIR 980067 REV 1 6 Page 6 77 The spirolab JIJ when used as a pulse oximeter is intended for spot checking overnight sleep screening and or continuous monitoring when attended by a trained healthcare professional 1 1 3 Operating environment The device has been envisaged for use in a doctor s office or in a hospital setting The information necessary for the proper use of the device in surrounding electromagnetic environments as required by EN 60601 1 2 is contained in the Annex The device is not intended for use in an operating theatre nor in the presence of inflammable liquids or detergents nor in the presence of inflammable anaesthetic gases oxygen or nitrogen The device is not designed to be used in direct air currents e g wind sources of heat or cold direct sun rays or other sources of light or energy dust sand or any other chemical substances The user and or the doctor are responsible
85. tructions An incorrect installation may cause damage to people animals or things in which the manufacturer is not to be considered liable Modifications adjustments repairs and reconfiguration must be carried out by the manufacturer or authorised persons In case problems arise do not attempt to personally repair the device The setting of configuration parameters must be carried out by qualified personnel In any case the risks pertaining to incorrect settings do not constitute a danger for the patient Inadequate respect to any of the above mentioned points may compromise the safety of the device Always respect the safety standards indicated for electrical devices in particular do not immerse the device in any type of liquid do not touch the device with wet or damp hands do not leave the device exposed to atmospheric conditions place the device on a stable and a level working surface for all maintenance operations use of the device always requires full mental ability e when unplugging the device never pull the cable of the power supply or of the device e always place the device on a suitable rigid horizontal on a stable surface with at least 30 cm 6 in of space all around the device The ventilation slots must be free from any cover or obstruction of any kind The ventilation slots are located both behind and underneath the plastic outer casing of the device Before plugging in the charging unit make sure that t
86. turbine is used do not clean it but replace it after each test I To avoid environmental contamination caused by the disposal of the cleaning solutions the user must follow all local regulations l 4 3 CLEANING AND DISINFECTION OF THE OXIMETRY SENSOR WARNING A Do not sterilize by irradiation steam or ethylene oxide Do not immerse in liquids Before cleaning or disinfecting the sensor unplug it from the monitor CAUTION A Betore cleaning or disinfecting the sensor unplug it from the device l Dau PRU a D CC l a a a al e x REC x l e Feci Clean the sensor with a soft cloth moistened with water or a mild soap solution To disinfect the sensor rub with isopropylic alcohol Allow the sensor to dry completely after cleaning spirolab III User Manual Code MIR 980067 REV 1 6 Page 65 77 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 In case the power supply of the battery reaching a high temperature then a thermal protection intervenes and prevent
87. turer This warranty covers the repair or the replacement at the discretion of the manufacturer of the product or of the defective parts without charge for the parts or for the labour All batteries and other consumable parts are specifically excluded from the terms of this guarantee The instrument must be returned to the authorized service centre for repair within 8 days from when the defect is detected This warranty is not valid at the discretion of the manufacturer in the following cases e f the fault is due to an improper installation or operation of the machine or if the installation does not conform to the current safety norms in the country of installation e f the product is utilized differently from the use described in the Users Manual improper incorrect and or unreasonable use etc e f any alteration adjustment modification or repair has been carried out by personnel not authorised by MIR or by the user e Ifthe fault is caused by lack of or incorrect routine maintenance of the machine e fthe machine has been dropped damaged or subjected to physical or electrical stress e f the fault is caused by the mains or by another product to which the instrument has been connected e fthe serial number of the instrument is missing tampered with and or not clearly legible This warranty does not cover any liability for damage caused directly or indirectly of any kind whatsoever for persons or things for the perio
88. volume curves spirometry parameters plus optional oximetry parameters The connection to the PC can be made in the following ways e through the RS232 port or e through the USB port The internal software or firmware of the device can be upgraded quickly and simply from a PC For upgrading the system consult the manufacturer or an authorized representative spirolab IIT gives an automatic interpretation of each spirometry test carried out and assigns a traffic light feedback green yellow or red to each test or series of tests The set up of the traffic light settings is made by the doctor responsible for the system configuration Oximetry function The oximetry sensor has two light emitting diodes LEDs one emits in the visible spectrum and one infrared Both lights then pass through the finger and are read by the receiver As these lights pass through the finger a proportion of the light is absorbed by the blood and by the soft tissue in function of the concentration of heamoglobin The quantity of light absorbed at each frequency depends on the degree of oxygenation of the haemoglobin inside the soft tissue This measurement principal ensures accuracy and reproducibility without requiring regular calibration The oximetry sensor can be disinfected with isopropilic alcohol for more information see paragraph 4 3 The operating battery is a 3 6V lithium battery spirolab III User Manual Code MIR 980067 REV 1 6 Page 2

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