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spirolab III User Manual

1. sssssee men 36 2 5 7 New subject data entiy eee Li nee bore Priests 37 2 5 8 Modify subject data eene eene eene nnne 39 2 6 Spirometry fvc vC IVC MW istriani akpi ite tere tee eae nue conta Teisa 39 2 6 1 Spiromietry testigo iieiea it reete eee teer leen entier tee n dee ed 40 2 6 2 Spirometry post drug sssssseeeeee eene nnne nnns 41 2 7 Visualisation of spirometry data ssseee 44 2 8 Test quality control spirometry ssssssssssssssseeeeneeen 45 2 9 Repeatability of the fvc test ionem cte eee edes 46 2 10 Method of measurement and interpretation ssssssssssssesses 46 2 11 OXimetry testing MT 47 2 11 1 SPOUOXIMERY uere Sorte ett ie PORE EEE 50 2 11 2 Sleep O ximeltry 2 Irem en MEO ERR RE RR 51 2 11 3 Exsercise oximelry nitet eene e tenore eet recs 52 2 11 4 Spot oximetry MEMORIZED LIKE OXYTEST eee 53 2 12 Fileorganiz tON ieuo Pm 53 2 13 Search and read tests in memory sssssssseeee eee 54 2 13 1 Subject List by last name ssssseeeen emm een 54 2 13 2 Subject List by ID code ssese emen 55 spirolab 7 77 User Manual Code MIR 980067 REV 2 0 Page 4 74 2 13 3 Memory List m 55 2 14 View and print reSults ccccccecccecece cece ceeeeeaeeeeeeeceeeeeaeeeeeeeseecesaeaeeeeeeeeeenanaees 55 3 DATA TRANSMISSION varrenn idee
2. NOD 90 periods above 5 minutes with minimum value hh mm ss lt 86 Nadir A DELTA Parameters measured during exercise test SYMBOL DESCRIPTION Units SpO2 Baseline SpO2 average before exercise ISpO2 End SpO2 after exercise SpO2 Min SpO2 minimum during exercise SpO2 Max SpO2 maximum during exercise SpO2 Mean SpO2 average during exercise BPM Baseline Average pulse frequency before exercise BPM BPM End Pulse frequency after exercise BPM BPM Min Pulse frequency minimum during exercise BPM BPM Max Pulse frequency maximum during exercise BPM BPM Mean Pulse frequency average during exercise BPM T90 Time passed with SpO2 90 hh mm ss T89 Time passed with SpO2 89 9o hh mm ss T88 Time passed with SpO2 88 hh mm ss 187 Time passed with SpO2 87 96 hh mm ss Time passed during exercise test with SpO2 2 m T2 ASpO2 gt 2 with respect to 5502 base RUES Time passed during SpO2 exercise test lt 4 T4 ASpO2 2 4 with d to SpO e hh mm ss T lt 40 BPM Time passed with pulse frequency lt 40 BPM hh mm ss T gt 120 BPM Time passed with pulse frequency gt 120 BPM hh mm ss Bradycar Events lt 40 Bradycardia events during the entire period of BPM analysis Tachycar Events gt 120 Tachycardia events during the entire period of BPM analysis Recording Time Total time measure of SpO2 hh mm ss Analysis Time Total time of analysis hh mm ss Baseline Time Duration of baseline phase hh mm
3. 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 spirolab ZIJ User Manual Code MIR 980067 REV 2 0 Page 48 74 The last oximetry test was interrupted before being properly completed A beeping sound will be simultaneously heard for 10 seconds Afterwhich the spirolab 777 main screen will appear The oximetry tests that can be performed by Spirolab III are SPOT OXIMETRY SLEEP OXIMETRY EXSERCISE OXIMETRY SPOT OXIMETRY MEMORIZED LIKE OXYTEST DOMI 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 maximise the signal strength WARNING A In order not to compromise the reproducibility of the measurements and the integrity of the sensor avoi
4. spirolab ZIJ User Manual Code MIR 980067 REV 2 0 Page 42 74 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 oQ significant broncodilatation with FEV1 POST 2 80 of predicted ORG significant broncodilatation with FEV1 POST lt 80 of predicted eG no significant broncodilatation WARNING A In the POST phase no test interpretation is given the test quality control messages are shown The POST test is available both in main with the characteristics of the patient and FILE in visualization of previous test SIS or m in this manner is easy to set post phase Visualizing the data stored the active keys are A Y e D ai a new spirometric test with patient selected for a POST test e E print out of the selected test e om EE for display FILE ms to go to the archivi menu EX 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 physiological 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 PO
5. 0t 00 00 00 T 120 BPM as 00 00 00 T88 SpO23 lt 85 ot 00 00 00 T87 SpO2 lt 87 ok 00 00 00 Total Desaturation Events 0 Total Pulse Rate Variations 1 ODI Desaturation Index O Pulse Rate Variation Index 12 0 Mean Duration Desat 5 0 Desaturation Peak Nadir 98 Longest Duration Desat s 0 Mean Desaturation t 0 NOD 4 Delta SpC2 gt 4 00 00 00 Mean Drop SpO2 0 NOD 89 lt 89 60 00 00 Max Drop SpO2 0 NOD 90 lt 90 Nadir lt 86 00 00 00 Made by spirolab III Signature spirolab IJ User Manual Code MIR 980067 REV 2 0 Page 68 74 Test Date 15 09 09 10 12 BTPS 1 092 Standard ERS ATS Name ID 8 Birth Date 04 11 1967 Age 41 Height cm 182 Weight kg 70 Sex M PRE File N 8 Predicted ERS FLOW L s Parameter PRE Predicted t FVC 6 03 5 08 119 FEVI 4 59 4 15 111 PEF 6 55 9 56 69 FVC 6 03 5 08 119 FEV1 4 59 4 15 111 FEV1 FVC 76 1 79 8 95 PEF 6 55 9 56 69 F2575 4 19 4 47 94 FEF25 6 41 8 28 34 FEF50 4 37 5 28 83 FEF75 2 19 2 34 94 FEV3 6 02 4 83 125 FEV3 FVC 99 8 9551 105 FEV6 6 03 5 08 119 FEV1 FEV6 76 1 61 93 FET 3 03 6 00 51 EVol 120 FIVC 6 14 5 08 121 FIV1l 4 71 4 15 113 FIV1 FIVC 76 7 79 8 96 PIF 6 30 9 56 66 ELA 41 41 100 MVV 160 7 145 6 110 VOLUME L Best Value Calculated Value INTERPRETATION Normal Spirometry QUALITY CONTROL GRADE F REPEATABILITY None spirolab IJ User Manual Code MIR 980067 REV 2 0 Page 69 74 INFORMATION FOR CORRECT USE I
6. Desaturation Event Desaturation events SpO2 fall gt 4 in a limited period of 8 40 sec and successive rise gt 2 within a total period of 150 sec Total Pulse rate Variation Pulse rate rise gt 10 BPM in limited period of 8 40 sec and successive fall gt 8 BPM during a total period of 150 sec spirolab ZIJ User Manual Code MIR 980067 REV 2 0 Page 18 74 Parameters measured during sleep oximetry SYMBOL DESCRIPTION Units SpO2 Baseline SpO2 Average in first three minutes SpO2 Min SpO2 Minimum during analysis period SpO2 Max SpO2 Maximum during analysis period SpO2 Mean SpO2 Average during analysis period BPM Baseline Average pulse frequency in the first 3 minutes BPM BPM Min Minimum pulse frequency during the analysis BPM period BPM Max sea pulse frequency during the analysis BPM BPM Mean ra pulse frequency during the analysis BPM Recording time Total time measure of SpO2 hh mm ss Analysis Time Total time of analysis hh mm ss T90 Time passed with SpO2 lt 90 _ hh mm ss T89 Time passed with SpO2 lt 89 hh mm ss T88 Time passed with SpO2 lt 88 hh mm ss T87 Time passed with SpO2 lt 87 9e hh mm ss 0 N SpO2 Events lt 89 Fall of SpO2 below 89 for at least 20 V seconds Index of SpO2 fluctuation calculated in A Index 12ses intervals of 12 sec T lt 40 BPM Time pa
7. 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 prevents 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
8. 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 spirolab H T User Manual Code MIR 980067 REV 2 0 Page 7 74 use of the device which differs from the original is to be considered improper and therefore dangerous The spirolab 7 7 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 in the European Standard EN 60601 1 2 spirolab ZJ 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 The safety and the correct performance of the device can only be assured if the user of the device respects all of the releva
9. spirolab 77 User Manual Code MIR 980067 REV 2 0 Page 51 74 This test records the variations in the patient s parameters overnight After approximately 5 minutes spirolab JJI 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 ZJ 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 11 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 following phase If the phase lasts for more than 6 minutes then spirolab ZJ will emit a beep as a reminder to pass to the exercise phase Exercise Phase At the be
10. 100 PRESS ANY KEY TO EXIT PASSWORD INCORRECT ENTER to Retry ESC to Quit Press 7 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 turbine 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 Each time a calibration is made the new correction factor is algebraically added to the previous correction factors Therefore before making a new calibration make 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 spirolab ZIJ User Manual Code MIR 980067 REV 2 0 Page 30 74 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 The values FVC and FIVC are retailed to the last calibration The values under the COR column indicate the actual correction They are set on O for COR TOTAL CORRECTION BTPS Measure condition default ATP Conversion from BTPS If FVC
11. 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 IVC test When the message VC IVC appears expire slowly as much air as possible and then inspire slowly as much air as possible EX 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 Le or wait 3 seconds after the last volume cycle At the end of any test the related curves and the main measured parameters are shown After viewing the curves press 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 tim
12. or to enter the details of a new patient Enter the required information using the cursor positioned on the subject s surname Use to go to the next entry CANI All data entered must be confirmed with 47 or cancelled with To modify a number after it has been entered use A to return the cursor to the area required to enter the correct numerical value and go to the next entry press qu ID Insert the patient ID code this code is alohanumerical and can be a maximum combination of 16 characters this code enables the quick recall of any patient data when 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 ID 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 lt to confirm the code press one of the arrow key to modify DATE OF BIRTH Insert patient data with the numeric keys spirolab 777 automatically calculates the patient age which is then shown in the space AGE Insert the other data using qe HEIGHT Enter the subjects height in cm or in inches according to the current configuration using the numeric keyboard Go to next entry using qu WEIGHT Enter the subject s weight
13. 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 et 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 SpO FCC ID TUK MIROO9 Warning symbol for the FCC spirolab ZZZ 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 this 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 a
14. 232 port WARNING A Note that when using the device in online mode if a turbine disposable or reusable is setup then the same turbine will remain by default the next time the device is used in stand alone mode Thus pay attention to the setting of the turbine 3 2 1 Connection to a PC through a USB port WARNING A Before connecting spirolab 777 to a PC via the USB port the winspiroPRO software must be installed to interface with the device Prior 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 77 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 77 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 JI For the correct management of the device see the software manual spirolab ZIJ User Manual Code MIR 980067 REV 2 0 Page 59 74
15. FEV1 VC PEF FEF2575 FEF25 FEF50 FEF75 FEV3 FEV3 FVC FEV6 FEV6 FET EVol FIVC FIV1 FIV1 FIVC PIF MVVcal VC EVC IVC IC ERV TV VE RR ti te TV ti t Ttot MVV ELA 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 2 13 SEARCH AND READ TESTS IN MEMORY FIND AND READ TESTS IN MEMORY Press to access menu from where to view all gt Subject List by Last Name test data stored in the memory of the device Subject List by ID code List by date The research can be made in three different Memory List manners Bluetooth transmission Subject list by last name Subject list by ID code List by date Memory list CHOOSE ANY FUNCTION Using amp and V select the me
16. aeiaaeeao ai nennen nenne KEE Aa nennen nennen 57 3 1 Data Transmission via Bluetooth to a cell phone eeseeeeese 57 3 1 1 Preliminary operations irri terere reb ge eere ee nte eos 57 3 1 2 Setting the Phone Number isinisisi inoen eeii 57 3 1 8 Data Transmission through Bluetooth een 57 3 1 4 Data Transmission via Bluetooth for printing 58 3 2 Connectiorito a pc oer tuere RP rp PR ortu E EE 59 3 2 1 Connection to a PC through a USB port sssese 59 3 2 2 Connection to PC through RS 232 port sssssssseee 59 3 3 Upgrade internal software necne eettee trente inet redes 60 4 MAINTENANCE AND CLEANING ssseeeee em eee errem nnne 60 4 1 Cleaning the device orcinec eterne die needed dedere ied 60 4 2 Cleaning the reusable turbine sssssssssssssseeeeneeeeeer enne 60 4 3 Cleaning and disinfection of the oximetry Sensor 62 5 PROBLEMS CAUSES AND SOLUTIONS eee emm eene 63 5 LIMITED WARRANTY CONDITIONS eee emm ener eere 65 nlmiclcm HQ 67 Example of testireport eter etes tr RARE S se Eee t t aE aE 68 Information for correct use in an electromagnetic environment sssssse 70 spirolab 7 77 User Manual Code MIR 980067 REV 2 0 Page 5 74 INTRODUCTION The spirometers series MIR
17. an acoustic alarm will ring to alert the user e activation disactivation of the acoustic alarm e setthe 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 then the cursor automatically pass to the next value if a value spirolab ZIJ User Manual Code MIR 980067 REV 2 0 Page 34 74 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 sec or press key 4 to set 4 sec Pressing the configuration menu is displayed Incentive spirolab 7 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
18. and FIVC 0 then use factory calibration ESC to Quit WARNING A ATP stands for Ambient Temperature and Pressure which indicates that the measurement conditions are ambient temperature 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 The correction of the inspired volumes and flows is made automatically as the device has an internal temperature sensor all parameters are thus reported at BTPS To make the calibration 1 Inser
19. and the last otherwise a single test pressing the number on numeric keys then press a Vv Read fie N EE 2 14 VIEW AND PRINT RESULTS WARNING A During a test session the device will automatically memorize up to 8 FVC tests M to view the results arranged in 8 sections on the screen Each of the 8 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 spirolab ZIJ User Manual Code MIR 980067 REV 2 0 Page 55 74 During the test session press 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 be 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 From the main screen it is possible to re examine and to print all the spirometry parameters Generates the Flow Volume curves of the best test Generates 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 TO print a t
20. around sensor for infants BCI 3043 universal Y sensor BCI 3078 ear sensor BCI 3178 pediatric finger sensor reusable BCI 3444 adult sensor reusable Comfort Clip BCI 3044 adult sensor reusable for finger 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 patients 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 spirolab ZIJ User Manual Code MIR 980067 REV 2 0 Page 12 74 Use only MIR sensors supplied with or specifically intended for use with the spirolab 777 Use of other types of sensors may cause inaccurate readings Oximetry measurements may be inaccurate in the presence of high ambient light 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 indigo carmine patent blu
21. expired in the initial 6 seconds of the test L FEV1 FEV6 FEV1 FEV6 x 100 FET Forced expiratory time S VEXT Extrapolated volume mL FIVC Forced inspiratory volume L FIV1 Volume inspired in the 1 second of the test L FIV1 FIVC FIV1 FIVC x 100 PIF Peak inspiratory flow L s MVVcal Maximum voluntary ventilation calculated from the FEV1 L s VC Slow vital capacity expiratory L ELA Estimated lung age years EVC Slow espiratory vital capacity L IVC Slow inspiratory vital capacity L IC Inspiratory capacity max between EVC and IVC ERV L ERV Expiratory reserve volume L TV Current volume L VE Ventilation per minute at rest L min RR Respiratory frequency Breath min tl Average time of inspiration at rest S tE Average time of expiration at rest S TV tI Average flow of inspiration at rest L min ti T tot te ti te MVV Maximum voluntary ventilation L min best values 1 6 2 Features of the oximeter Measurement method Red and infrared absorption Range of measurement 5SpO 0 99 with 1 increments SpO2 accuracy 296 between 70 99 SpO2 Average number of heart beats for the SpO2 calculation 8 beats Range of measurement of cardiac pulse increments 30 254 BPM with 1 BPM Accuracy of cardiac pulse 2 BPM or 2 Average interval for the calculation of cardiac pulse 8 seconds Signal quality indication 0 8 segments on display Definitions
22. 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 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 spirolab IJ User Manual Code MIR 980067 REV 2 0 Page 63 74 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 ZI
23. 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 Accurate measurement even at very low flow rates end of expiration Not influenced by gas humidity nor density Shockproof and unbreakable Inexpensive to replace The turbine flow measurement sensor is available both in reusable and in single patient disposable versions REUSABLE TURBINE DISPOSABLE TURBINE spirolab ZIJ User Manual Code MIR 980067 REV 2 0 Page 22 74 The following precautions must be observed to ensure that the characteristics 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 safe
24. ss Exercise Time Duration of exercise phase hh mm ss Time for SpO2 value 2 99 of the average base Recovery Time value calculated during the initial phase of the hh mm ss test DYSPNEA Baseline Variation in grade of dyspnea during Baseline DYSPNEA End Final grade of dyspnea DYSPNEA CHG Variation in grade of dyspnea during exercise FATIGUE Baseline Variation in grade of fatigue during Baseline FATIGUE End Final grade of fatigue Fatigue CHG Variations in level of fatigue during exercise A DELTA Parameters required for exercise test SYMBOL DESCRIPTION Units spirolab ZIJ User Manual Code MIR 980067 REV 2 0 Page 20 74 SYMBOL DESCRIPTION Units Baseline DYSPNEA Grade of dyspnea before exercise Final DYSPNEA Grade of dyspnea after exercise Baseline FATIGUE Level of fatigue before exercise Final FATIGUE Level of fatigue after exercise Parameters measured with SpO2 Analysis SYMBOL DESCRIPTION Units SpO2 Baseline SpO2 Average in first three minutes SpO2 Min SpO2 Minimum during analysis period SpO2 Max SpO2 Maximum during analysis period SpO2 Mean SpO2 Average during analysis period BPM Baseline Average pulse frequency in the first 3 minutes BPM BPM Min oed pulse frequency during the analysis BPM BPM Max sed pulse frequency during the analysis BPM BPM Mean ACE pulse frequency during the analysis BPM Recording time Total tim
25. 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 7 will automatically select and show the best test and measured parameters To end test press or just wait for 10 seconds after the last volume cycle the test terminates automatically spirolab ZIJ User Manual Code MIR 980067 REV 2 0 Page 40 74 WARNING A In the 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
26. the data in memory for two different operations etransfer to a cell phone which then transmits the data to a PC by modem etransfer to a Bluetooth enabled printer The following paragraphs contain in depth information on these two procedures 3 1 DATA TRANSMISSION VIA BLUETOOTH TO A CELL PHONE WARNING A spirolab 77 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 ZIT 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 MENI With spirolab 777 switched on press uv e e Use vertical scroll key to select Bluetooth settings then press e Use vertical scroll key to select insert telephon number then press ea e Enter the number with the numerical keyboard and again press qx the Bluetooth Menu will appear ES e Use 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 tr
27. the power supply jack into the socket on the back of the device Do not use the power supply if it is wet or damp f 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 Before using the device proceed with the cleaning operations as described in the MAINTENANCE AND CLEANING section Lift the LCD display release the catch Press the red on off key on the upp
28. wood concrete or ceramic tile If t 8 kV air t 8 kV air floors are covered with IEC 61000 4 2 synthetic material the relative humidity should be at least 30 96 Electrical fast 1 kV for 1 kV for Mains power quality should transient burst input output input output be that of a lines lines typical commercial or IEC 61000 4 4 hospital environment Surge 1kV 1 kV differential Mains power quality should differential mode mode be that of a typical IEC 61000 4 5 commercial or hospital 2 kV common mode 2 kV common mode environment Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 5 UT gt 95 dip in UT for 0 5 cycle 40 UT 60 96 dip in UT for 5 cycles 70 UT 30 96 dip in UT for 25 cycles 5 UT gt 95 dip in UT for 0 5 cycle 40 UT 60 96 dip in UT for 5 cycles 70 UT 30 96 dip in UT for 25 cycles 5 UT 5 UT gt 95 dip in UT gt 95 dip in for5 sec UT for 5 sec Power frequency 3 A m 3 A m Power frequency magnetic 50 60 Hz fields should be at levels magnetic field characteristic of a typical location in a typical IEC 61000 4 8 commercial or hospital environment NOTE UT is the a c mains voltage prior to application of the test level spirolab ZIJ User Manual Code MIR 980067 REV 2 0 Page 71 74 Guidance and manufacturer s declaration electromagnetic i
29. 3 3 UPGRADE INTERNAL SOFTWARE spirolab 77 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 JJI is an instrument that requires very limited maintenance The operations to perform periodically are Cleaning and controlling of the reusable turbine Changing the disposable turbine at each test Cleaning of the oximetry sensor for reusable sensors Changing the adhesive tape of the oximetry wrap sensor 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 replace
30. ENCE ADULTS CHILDREN 1 ERS Knudson 2 Knudson Knudson 3 Morris Bass Knudson 4 ERS Zapletal 5 MC Barcelona Zapletal Select with the numeric keys the reference number automatically the chosen values will set and the display shows the configuration menu Select printout To enable or disable the printout of spirometry parameters best values of FVC FEV1 FEV1 FVC PEF FEF2575 the last one is always relative to the best test spirometry interpretation F V and V t curves Bluetooth settings Select this function and the following menu is shown e Search Device e Options PRINTER e Options PHONE e Remote line Number Search Device Select the required option with and confirm with S spirolab H T 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 oras a phone use PRINTER or PHONE select one of the two options and push 7 otherwise spirolab ZIJ User Manual Code MIR 980067 REV 2 0 Page 33 74 EX push Le 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 having selected a device it is possible and e to set the device as default identi
31. ING Follow carefully all of the instructions given in the various paragraphs of this manual to ensure that all of the functions operate correctly Remove the used mouthpiece and dispose of it after finishing the spirometry testing When the flow sensor head is not in use we recommend that it is kept in its compartment Press lightly on the connector to detach the flow sensor turbine from the socket on the left hand side of the device and proceed with 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 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 spirolab ZIJ User Manual Code MIR 980067 REV 2 0 Page 28 74 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 correspo
32. IPTION On Off Adjust contrast Adjust brightness Advance the printer paper Self check key Cancel the current operation Select configuration menu Correction key cancel last data inserted spirolab ZIJ User Manual Code MIR 980067 REV 2 0 Page 24 74 SYMBOL DESCRIPTION t Information about options FILE View data in memory o ID Enter modify patient data S View best test View last test CG View last oximetry test ross Make POST test Make oximetry test O Print Fve Make FVC test ve Make VC test MVV Make MVV test Number keys Specifies female sex Specifies male sex q Confirm last operation This key is the ENTER key A KI pi Move cursor val 2 3 CHARGING THE BATTERY WARNING A spirolab 777 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 WARNING A For charging internal battery of spirolab ZIJI use exclusively the battery charger provided with the device MIR code 920665 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 spirolab ZIJ User Manual Code MIR 980067 REV 2 0 Page 25 74 Plug
33. J User Manual Code MIR 980067 REV 2 0 Page 64 74 5 LIMITED WARRANTY CONDITIONS This MIR product together with its standard accessories is guaranteed for a period of ONE YEAR from the date of purchase In the case of any warranty claims the relevant sales invoice or another proof of purchase document must be submitted to MIR The instrument must be checked at the time of purchase or upon delivery and any claims must be made within 8 days in writing to the manufacturer 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 If 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 by the user or by personnel not authorised by MIR e Ifthe fault is caused by lack of or in
34. Manual Code MIR 980067 REV 2 0 Page 66 74 ANNEXES gon MIR t ANNE MEDICAL INTERNATIONAL RESEARCH Via del Maggiolino 125 00155 Roma ITALY wEDICA DECLARATION OF CONFORMITY CE annex II excluding par 4 We hereby declare that the following device Type Spirometer Brandname MIR Medical International Research Device name spirolab III Class IIa Complies with the Essential Requirements of directive 93 42 EC concerning Medical Devices and its amendments and its transposition in the Member States This statement is made on the basis of the CE Certificate n MED 9826 issued by Cermet Notified Body n 0476 Rome 01 01 2011 Brel Paolo Sacco Boschetti The Chairman spirolab JJ User Manual Code MIR 980067 REV 2 0 Page 67 74 EXAMPLE OF TEST REPORT Oximetry Sleep Test DATE 24 08 06 TIME 16 10 Ver 0 5 NAME Kkkl Iou BIRTH DATE 01 05 1975 ID 2 AGE 31 HEIGHT cm 180 SEX M WEIGHT Kg 78 Spo2 Graph 252388585 1 2 3 4 5 6 B Pulse Rate Graph 168 148 128 108 80 60 46 28 1 2 3 5 6 B 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 40 BPM 0 Delta Index 12 sec 3 WN Tachycardia Events gt 120 BPM 0 time hh mm ss time hh mm ss T90 SpO2 lt 90 oe 00 00 00 T lt 40 BPM ot 00 00 00 T89 SpO2 lt 89
35. N AN ELECTROMAGNETIC ENVIRONMENT Guidance and manufacturer s declaration electromagnetic emissions The spirolab JI is intended for use in the electromagnetic environment specified below The customer or the user of the spirolab ZII should assure that it is used in such an environment Emissions test Compliance Electromagnetic environment guidance RF emissions Group 2 The spirolab ZII must emit CISPR 11 electromagnetic energy to perform its indended function Nearby electronic equipment can be affected RF emissions Class B The spirolab JI is suitable CISPR 11 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 Class D IEC 61000 3 2 Voltage fluctuations Complies flicker emissions IEC 61000 3 3 spirolab ZIJ User Manual Code MIR 980067 REV 2 0 Page 70 74 Guidance and manufacturer s declaration electromagnetic immunity The spirolab JI is intended for use in the electromagnetic environment specified below The customer or the user of the spirolab ZII should assure that it is used in such an environment Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Electrostatic discharge ESD t 6 kV contact 6 kV contact Floors should be
36. NG A For standard NAHNES III the parameters shown are FEV6 FEV1 FEV1 FEV6 FEF2575 FVC FEV1 FVC By visualising the single curve it is then possible to directly carry out a new spirometry PRE or POST test or oximetry test On the current patient by pressing respectively one of the following keys re Lv POST wr ror e You can also do this if you recall a best test by selecting key or the last test by selecting key for spirometry or key for oximetry the test selected will be carried out on the current patient spirolab ZIJ User Manual Code MIR 980067 REV 2 0 Page 44 74 WARNING A If the last spirometry test carried out was a POST test the POST session should be maintained until a new patient is recalled from the archivi or a new patient created 2 8 TEST QUALITY CONTROL SPIROMETRY 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 This control quality check assigns a letter for the current session as described below PRE Test A At least two acceptable manoeuvres with the highest two FEV1 values matching to within 100 mL and the largest two FEV6 values within 100 mL B At least two acceptable manoeuvres with the FEV1 values matching to within 101 to 150 mL C At least two acceptable manoeuvres with FEV1 values matching to
37. OO9 are sold with the spirolab ZZ trademark spirolab J 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 ZJ 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 ZII 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 particular WARNING on cleaning operations cross contamination risk all require qualified personnel WARNING 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 JII 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 The spirolab 7 7 when used as a pulse oximeter is intend
38. ST 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 The 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 19 ID To end the POST phase and make new PRE tests press o and then pi spirolab IJ User Manual Code MIR 980067 REV 2 0 Page 43 74 WARNING A If a new dose is set after a POST test then the device creates a new test session still POST A new test code ID is allocated The interpretation is not based on the previous sessions with different drug doses only the new test is utilized for the interpretation 2 7 VISUALISATION OF SPIROMETRY DATA The image below describes the information which appears inside the spirometry test results screen Colour coded test review keys Patient S A Martini 28 05 07 EFFI lt Date and time of current test Predicted Value Area of current patient Best results Flow Volume curves _ __ Obstruction Restriction evaluation Post test evaluation 4 5 6 3 CIE PRE 1 C LONE 1 V 5 35 3 88 3 53 FE 4 50 3 22 2 16 FEVIFVC 82 5 83 0 61 2 Test results PRE1 PRE2 PRES In particular in this screen it is possible to visualise the data relative to a single curve by pressing respectively key 1 2 or 3 starting from the best test onwards WARNI
39. TERNATIONAL RESEARCH FCC iD TUK MIROOB MEDICAL ENTRRNATRONAL RESEARCH FGC D TUK MIRODS Rx DNLY Rx ONLY Pacte hy AT Male hy Ati Via del Maggiolino 175 C kd Via del Maaginlino 145 C ket 00155 ROME ITALY 0476 LA e NIES WOME ITALY 0476 M 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 Warning symbol for the connection of the power supply e To charge the internal battery use only and exclusively the original power supply 12 V 1A DC MIR code DC IN 12 V 920665 guaranteed and certified to the EN 60601 1 Safety Standard spirolab IJ User Manual Code MIR 980067 REV 2 0 Page 14 74 JN Turene Warning symbol for the turbine connector DC OUT C3 Use only and exclusively the original turbine flow sensor SY Warning symbol for the serial port To connect other devices such as PC or printer to the RS 232 serial port
40. 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 e use by non qualified or non trained personnel lacking ability or experience e user error e use of the instrument outside the guidelines described in this User s Manual spirolab ZIJ User Manual Code MIR 980067 REV 2 0 Page 13 74 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 If the archive is corrupted the following message appears THE INTERNAL ARCHIVE STRUCTURE IS CORRUPTED Press any key the device requires the password 122333 to cancel all data in memory if necessary download archive with winspiroPRO and then insert password to cancel the device memory WARNING A Following the European Directive 93 42 EEC for MEDICAL 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 AS SN A23 053 00000 p NN SN A23 054 0D000 N N NN MIR REF spirolab 44 colour NN MIR REF epirolab sr bw MEDICAL IN
41. VC and MVV tests can be performed Frye ve Mvv In the POST phase having selected one of these three tests L2 Lv or e 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 column 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
42. an age of 4 or below is selected then spirolab 777 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 Standard To select one of the available standards ATS ERS or NANHES III press ee WARNING A With the standard NAHNES IlI is not possible to select or to modify the predicted values 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 7 to toggle 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 spirolab ZIJ User Manual Code MIR 980067 REV 2 0 Page 35 74 Press to toggle 2 5 6 Functioning of the spirometer spirolab JIT performs the following Y measurements Fve Forced Vital Capacity The valuation and interpretation of test ve Slow Vital Capacity results are given by comparing the EXE UE measured parameters with specific Maximum Voluntary Ventilation normal spirometry values known as spo predicted values which are calculated SpO2IBPM from subject data age height weight s
43. 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 777 B W Graphic LCD passive type FSTN 320x240 Pixel spirolab 777 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 the spirometer Measured parameters SYMBOL DESCRIPTION Units FVC Best FVC L FEV1 Best FEV1 L PEF Best PEF L s FEV FVC Best FEV1 FVC FVC Forced Vital Capacity L FEV1 Volume expired in the 1 second of the test L FEV1 FVC FEV1 FVC x 100 FEV1 VC FEV1 best between EVC and IVC x 100 PEF Peak expiratory flow Lis FEF2575 Average flow between 25 and 75 of the FVC L s FEF25 Forced Expiratory Flow at 25 of FVC L s FEF50 Forced Expiratory Flow at 50 of FVC L s spirolab ZIJ User Manual Code MIR 980067 REV 2 0 Page 17 74 SYMBOL DESCRIPTION Units FEF75 Forced Expiratory Flow at 75 of FVC L s FEV3 Volume expired in the initial 3 seconds of the test L FEV3 FVC FEV3 FVC x 100 FEV6 Volume
44. ansmission and press qa 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 spirolab 77 User Manual Code MIR 980067 REV 2 0 Page 57 74 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 Z e are executed all the next connection steps When the connection is active data are transmitted from the selected modem At the end of the transfer data process the following message Connection Completed is shown The screen will show the following information e The device used for the connection e The pre set phone number e The preset PIN corresponding to the serial number of the device 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 adapter can be installed on the printer in order to enable a Bluetooth connection The printer use
45. aper roll holder Push the paper into the slot located under the traction reel black rubber reel A sensor as indicated in the image detects the paper and automatically advances it This image shows the position of the paper in relation to the traction reel 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 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 spirolab ZIJ User Manual Code MIR 980067 REV 2 0 Page 27 74 suitable for printers with a printing speed of 50 mm s This type of paper is easy to find at most medical device dealers 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 IIT 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 WARN
46. 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 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 For instance if the calibration procedure is carried out with measured data 20 C FVC 3 08 FIVC 3 30 the spirometer is perfectly calibrated and the relative correction factors are null No calibration is required This does not represent an error but is a logical consequence of the above detailed explanation spirolab ZIJ User Manual Code MIR 980067 REV 2 0 Page 32 74 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 Vb 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 ESC to Quit 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 REFER
47. ced Contact an authorised 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 spirolab ZIJ User Manual Code MIR 980067 REV 2 0 Page 10 74 1 2 1 Danger of cross contamination Two different types of turbine sensors can be used with the device one is reusable and one is single patient disposable A mouthpiece is required in order to connect a subject to the spirometer In order to avoid exposing the subject to the critical danger of cross contamination the reusable flow sensor must always be cleaned before each spirometry test and always use a new disposable mouthpiece for each subject 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 If you are going to perform the
48. correct routine maintenance of the machine e f the machine has been dropped damaged or subjected to physical or electrical stress e If the fault is caused by the mains or by another product to which the instrument has been connected e Ifthe 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 period 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 ZIJ User Manual Code MIR 980067 REV 2 0 Page 65 74 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 ZIJ User
49. ctor 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 Spo2 Quality of signal received BPM Test time extension Time curve of the two parameters SpO2 and BPM Test type in esecution Possible warning message ES To end test press To print data see Paragraph 3 1 2 see example of the test printout report attached to this Manual 2 11 2 Sleep Oximetry To chose this test press 2 on numeric key
50. d All data not to be modified must be confirmed by pressing v 2 6 SPIROMETRY FVC VC IVC MVV WARNING A When connecting the spirometry sensor to the device ensure that the connector has the arrow side UP towards you When correctly inserted the connector will click into place See the following image spirolab ZIJ User Manual Code MIR 980067 REV 2 0 Page 39 74 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 Fve To make the FVC test To make the VC IVC and ventilatory profile tests s To make the MVV test WARNING A With standard NAHNES III it is not possible to make VC or MVV tests 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 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
51. d must be in the list of printers accepted by the device To have a copy of the updated list please contact the manufacturer or send an email to the following address mir spirometry com The Bluetooth system enables spirolab ZJ 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 JJI will carry out the phases of connection e At the end of the transmission spirolab 77I 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 BX 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 press twice spirolab ZIJ User Manual Code MIR 980067 REV 2 0 Page 58 74 When searching for Bluetooth enabled devices spirolab 7I 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 A PC spirolab ZZ can be connected to a PC and perform tests online Two connection types are used USB port or RS
52. d 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 ZII 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 777 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 71 emits a beep for 10 seconds 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 spirolab JJI User Manual Code MIR 980067 REV 2 0 Page 49 74 fii symbol on the display will be seen and this can be activated disactivated by pressing KI 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 11 1 Spot oximetry WARNING A The sensor described below is for illustration purposes only spirolab Z is enabled for the use of any of the sensors
53. deposited inside Leave the turbine immersed for the time specified in the instructions of the solution Miniflowmeter Turbine Mouthpiece WARNING A To avoid any kind of damage to the reusable turbine please do not use any alcoholic or oily substances do not immerge the turbine in hot water or hot solution Do not put the turbine under a direct jet of water or other liquid If no detergent solution is available clean the turbine in clean water MIR suggest the use of Perasafe manufactured by Dupont which has been tested with positive results on all MIR sensors Rinse the turbine by immerging it in clean water not hot 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 Veri
54. described in 81 2 4 MIR does not recommend the 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 e Place the patient s digit in the sensor nail side up lining up the digits pad over the detector The sensors positioning line runs across the mid axis of the fingertip spirolab ZIJ User Manual Code MIR 980067 REV 2 0 Page 50 74 e Wrap the bottom adhesive around the digit being careful not to cover the nail e Fold the sensors top over the digit making sure the light source is directly over and in line with the dete
55. e 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 accurate 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 Optical cross talk can occur when two or more sensors are placed in close 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 damage Do not attempt 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 1 3 PROBLEMS AND
56. e 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 spirolab ZIJ User Manual Code MIR 980067 REV 2 0 Page 41 74 1 case current patient data To perform a POST test on the current subject after completing e PRE test follow these instructions POS Press 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 2 case subject file To perform a POST test on a patient already in memory firstly recall from memory the relavant PRE test spirometry parameters from the same subject file Press select using one of the research metods the PRE file Confirm with eA Press V to set a new test with the same patient Press rs 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
57. e measure of SpO2 hh mm ss Analysis Time Total time of analysis hh mm ss T90 Time passed with SpO2 lt 90 hh mm ss r89 Time passed with SpO2 lt 89 96 hh mm ss 88 Time passed with SpO2 lt 88 hh mm ss T87 Time passed with SpO2 lt 87 96 96 hh mm ss Fall of SpO2 below 89 for at least 20 0 N SpO2 Events 8996 second Index of SpO2 fluctuation calculated in A Index 12sec intervals of 12 seconds l T lt 40 BPM Time passed with pulse frequency lt 40 BPM hh mm ss T gt 120 BPM Time passed with pulse frequency gt 120 BPM hh mm ss Bradycar Events 40 BPM Bradycardia events during the entire analysis period Tachycar Events gt 120 BPM Tachycardia events during the entire analysis period A DELTA Acoustic signals for oximetry e Beep with frequency of the cardiac pulse e Continuous beep in the case of either SpOz2 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 sound for 10 seconds e Ifthe 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 spirolab ZIJ User Manual Code MIR 980067 REV 2 0 Page 21 74 The specifications for both the oximet
58. ed 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 spirolab 7 77 User Manual Code MIR 980067 REV 2 0 Page 6 74 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 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
59. er 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 power on as the power supply is internal 2 5 SETTINGS spirolab IJ User Manual Code MIR 980067 REV 2 0 Page 26 74 Backlight settings The brightness of the display is a factory setting and cannot be adjusted 2 5 1 Contrast settings The contrast of the display can be adjusted by using the keys The left arrow increases the contrast and the right arrow decreases it Keep the key pressed without using excessive force to adjust the contrast to your liking After adjusting the contrast of the display wait 5 seconds after releasing the key for the device to memorize the new contrast setting before turning off the Spirolab Ill 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 Guide to the correct positioning of the p
60. est saved on file after recalling it press To interrupt printing press The printout report includes a header line with the date time the BTPS value at the time of the test patient details the FILE No any pre set ethnic correction factor and the predicted value set used 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 8 Junie 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 spirolab ZIJ User Manual Code MIR 980067 REV 2 0 Page 56 74 RA From the measured parameter s screen RS or key 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 IT includes a Bluetooth wireless data transmission system This connection is via radio and allows the transferring of all
61. ex and ethnic group only for spirolab 7177 with colour display 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 e Knudson g Morris Bass E Multicentrico Barcellona For children Knudson 5 Zapletal After each test session the results are compared to the selected predicted values and the percentage ratio between measured and predicted is shown for each parameter Predicted Measured x 100 The test can be repeated more than once and the best result is memorized in order to be recalled from the spirolab J I 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 ZII displays and prints the Flow Volume and the Volume time curves superimposed with PRE and POST parameter comparison and percentage of change Value POST 0 z APRE Value PRE X00 spirolab ZIJ User Manual Code MIR 980067 REV 2 0 Page 36 74 After switching on the device the main screen Nj Spir
62. 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 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 operations 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 The lithium battery is continuously monitored by the device if the battery is discharged a warning message indicates that it must be repla
63. fied with a yellow point near the device name so spirolab ZT will automatically connect to this e to delete the device from the list spirolab ZII asks for a confirmation by pressing PE 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 search for active devices ESX press 1 to start the search or Le to return to the Bluetooth settings Options PHONE AS To control the devices memorized in the printers list Enter the list with selected a device it is possible and having e to set the device as default identified with a yellow point near the device name and spirolab ZT will automatically connect to this e to delete the device from the list spirolab ZII asks for a confirmation by pressing pr ES otherwise press to return to the Bluetooth options and not delete the device from the list Even if the list is empty a search can be made for active devices as previously described Remote line Number Enter the menu with 47 then it is possible to insert the telephone number that spirolab ZZ will use to connect to a Bluetooth telephone Insert the required number using the numeric keyboard and then press qe 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
64. fy the free movement of the turbine e Switch on spirolab JJ as if to make a spirometry test for example FVC e Hold the MiniFlowmeter in one hand and move it gently from side to side so that air passes through the turbine spirolab ZIJ User Manual Code MIR 980067 REV 2 0 Page 61 74 e f 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 turbine is used do not clean it but replace it after each test To avoid environmental contamination caused by the disposal of the cleaning solutions the user must follow all local regulations 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 device 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 ZIJ User Manual Code MIR 980067 REV 2 0 Page 62 74 5 PROBLEMS CAUSES AND SOLUTIONS The device does not switch on Press firmly on the on key The internal battery may be discharged
65. ginning 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 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 ZZ 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 el the timer re sets to zero ES To end test press At the end of the test the data required for the calculation of the parameters must be inserted more specifically spirolab ZIJ User Manual Code MIR 980067 REV 2 0 Page 52 74 Baseline DYSPNEA SCALE SEVERITY e e Final DYSPNEA 0 None e Baseline FATIGUE 0 5 Very Very Slight Just Noticeable e Final FATIGUE 1 Very Slight 2 Slight These follow the Borg scale and 3 Moderate can have the following values 0 4 Some What Severe 0 5 1 2 3 4 5 6 7 8 9 10 5 Severe 6 The Borg scale coefficients 7 Very Severe represent the following severity 8 values 9 Very Very Severe Almost Maximum 10 Maximum Use KI and p to enter data use 7 or A to go back or pass to next data Exercise test data results are given in t
66. he following screen and can be printed as described in Paragraphs 2 13 and 3 1 2 if the test results are printed the test printout will only show the exercise test results an example of a test printout report is attached 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 SpO2 value to return to at least 99 of the average base value calculated during the initial phase of the test 2 11 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 12 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 repeatability and quality control test information Parameters stored with the FVC test spirolab IJ User Manual Code MIR 980067 REV 2 0 Page 53 74 FVC FEV1 FEV1 FVC
67. he 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 spirolab ZIJ User Manual Code MIR 980067 REV 2 0 Page 11 74 Any disposable mouthpieces included with the device are supplied UU 7 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 Use a bio compatible mouthpiece to avoid any problems to the patient unsuitable materials could cause a bad functioning of the instrument and therefore the test 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 1 2 4 Oximetry sensor The following oximetry sensors can be used with spirolab ZI MANUFACTURER MANUFACTURER CODE DESCRIPTION BCI 1300 adult sensor disposable BCI 3026 wrap
68. in Kg or Pounds according to the current configuration using the numeric keyboard Go to next entry using v SEX Select gender using the keyboard I male and o Iam female ETHNIC GROUP Select one type of ethnic group enter the number corresponding to the required ethnical group Press 0 for no conversion factor This function allows the correction of the predicted values for a subject with the ethnic group to which he or she belongs spirolab ZIJ User Manual Code MIR 980067 REV 2 0 Page 38 74 ATS ERS Standard NAHNES III Standard Group correc Caucasian Without correction 100 African American Caucasian 100 Mexican American Oriental 100 Others Hong Kong Chinese 100 Japanese 89 Polynesian 90 North Indian 90 South ndian 87 Pakistan 90 African Descent 87 For ATS ERS standards the correction is applied to the predicted values of the following parameters FVC FEV1 FEV3 FEV6 VC For NAHNES Ill standards the correction is based on several theoretical formulas as described in the publication 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 2 5 8 Modify subject data ID To modify subject data press and then
69. 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 777 is used exceeds the applicable RF compliance level above the spirolab 777 should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the spirolab ZI b Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m spirolab ZIJ User Manual Code MIR 980067 REV 2 0 Page 73 74 Recommended separation distances between portable and mobile RF communications equipment and the Spirloab Ill The spirolab JII is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the spirolab ZII can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the spirolab ZII as recommended below according to the maximum
70. ment 4 1 CLEANING THE DEVICE Clean the device with a damp cloth Make sure to dry it afterwards WARNING A Do not wet or immerse the device or power supply in any liquids Do not use any abrasive materials to clean the device 4 2 CLEANING THE REUSABLE TURBINE The turbine utilized with spirolab ZII is of one of two categories disposable or reusable These guarantee precise measurements and have the advantage of requiring no periodic calibration In order to maintain these characteristics a simple cleaning is required prior to each use only for the reusable turbine 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 ZIJ User Manual Code MIR 980067 REV 2 0 Page 60 74 WARNING A It is good practice to control from time to time that dirt or foreign bodies such as threads or hair are not deposited inside the turbine Any such deposit could brake or block the blade of the turbine and thus compromise the measurement accuracy 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 Immerse the turbine in a cold detergent solution and move it within the liquid to remove any impurities which may be
71. mmunity The spirolab JI is intended for use in the electromagnetic environment specified below The customer or the user of the spirolab ZI should assure that it is used in such an environment Immunity test IEC 60601 test Compliance level Electromagnetic environment Conducted RF IEC 61000 4 6 Radiated RF IEC 61000 4 3 level guidance Portable and mobile RF communications equipment 3 Vrms 150 kHz to 80 MHz 3 Vim 80 MHz to 2 5 GHz 3 V 3 V m should be used no closer to any partt of the spirolab JMI including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance d 3 5 VP 3 d 3 5 NP 80 MHz to 800 GHz 3 d 7 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 distance in metres m Field strengths from fixed RF 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 Kp NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies spirolab ZIJ User Manual Code MIR 980067 REV 2 0 Page 72 74 NOTE 2 These guidelines may not apply
72. nd 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 provide reasonable protection against harmful interference in a residential installation This equipment generates uses and can radiate radio frequency energy and if not installed and used in accordance with the instructions may cause harmful interference to radio communications spirolab JJ User Manual Code MIR 980067 REV 2 0 Page 15 74 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 measures Re orient or relocate the receiving antenna Increase the distance between the equipment and receiver 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 Memory spirometric tests The precise number depends on the individual configuration so it cannot be determined more closely Interface RS232 USB Bluetooth Flow volume measurement system Bi directional digital turbine Measurement method Infrared inte
73. nd to the wording shown on the screen of the device spirolab JI allows for the personalised setting of certain parameters through the Configuration Menu To access the configuration menu with the device switched on press ES which contains the following list e Delete data in memory e Print last calibration e Turbine calibration e Printout header text e Change Date Time e Choose operating language e Choose predicted values e Setup parameters printout e Bluetooth settings e Oximetry settings e Incentive e Turbine type e Standard e Date format e Units format e Auto power off function available only for spirolab III with colour display Select the required option using or V until the gt symbol on the left of the screen is alongside your selection then press to access the option MENU Use this key to recall the Configuration Menu to set up and or to change certain main functions of the device 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 ES Use Le to quit without deleting the test data TO PROCEED INSERT PASSWORD The password is 122333 spirolab ZIJ User Manual Code MIR 980067 REV 2 0 Page 29 74 After deleting the data in memory the display shows If the password is entered incorrectly Test data has been DELETED the display shows Available memory is
74. nt 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 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 of the user to follow these instructions correctly misuse of the device whether that 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 be detected Keep the device away from hot and or cold sources The thermal paper used for printing is highly inflammable Keep away from open flames High frequency emissions that are outside the limits expressed by the EN60601 1 2 may interfere with the co
75. o 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 The interpretation during a test session for each subject always refers to the best test results made by that subject 2 11 OXIMETRY TESTING spirolab ZII can carry out different types of oximetry tests which are described in the following paragraphs WARNING If spirolab 7 7 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 JII is enabled for the use of any of the sensors described 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
76. olab III ver v xy will show mm f th urrent patient doin xL E E cl DATE 23 05 06 TIME 12 44 00 Some values shown are as follows FILEN 1 MEMORY o IY OO V x y Indicates the version of the software LAST NAME firmware inside the spirometer In case of FIRST NAME iD technical problems always note this version BIRTH DATE ororo number HEIGHT em 0 AGE WEIGHT kg 0 SEX DATE AND TIME ETHNIC G Caucasico The current date and time which can be TYPE OF TURBINE REUSABLE modified from the Configuration Menu STANDARDIN USE ATS ERS BTPS 1 087 CHOOSE ANY 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 JII 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 8D 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 Press io 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 spirolab ZIJ User Manual Code MIR 980067 REV 2 0 Page 37 74 Use KI or p to modify data of a patient already inserted
77. or 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 spirolab 7 77 User Manual Code MIR 980067 REV 2 0 Page 2 74 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 7 77 User Manual Code MIR 980067 REV 2 0 Page 3 74 INDEX INTRODUCTION 6 1 GENERAL INFORMATION esee enm nene en nennen nene nennen nnne 6 1 1 Intended USE D 6 1 1 1 User Category ertet ee Ae i i EE aad 6 1 1 2 Ability and experience required ccccceceeeeeeeeceeceeeeeeeeeeeaeeeeeeeseeeenaeeeeeeeees 6 1 1 3 Operating environment teen eerte E ihr ad E scone c Ree 6 1 1 4 Who can or must make the installation 7 1 1 5 Subject effect on the use of the device 7 1 1 6 Limitations of use Contraindications se m 7 1 2 Important safe
78. 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 NP d 3 5 NP de 7 NP V4 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 d in 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 ZIJ User Manual Code MIR 980067 REV 2 0 Page 74 74
79. 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 lt 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 lt 1 0 L then FEV1 repeatable when the difference between the two largest FEV1 is lt 100 mL FVC repeatable when the difference between the two largest FVC is lt 100 mL 2 10 METHOD OF MEASUREMENT AND INTERPRETATION Spirometry test interpretation is based on the Forced Vital Capacity FVC test and is based on the ATS standard For a faster comprehension this interpretation is illustrated by a traffic light code green yellow red For each test made an arrow on the right of the screen indicates the worst level of interpretation of the test session 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 vortex in the passing air around the axis of the sensor A rotor with a speed of rotation directly proportional to the air flow then inte
80. rrect 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 spirolab 7 77 User Manual Code MIR 980067 REV 2 0 Page 8 74 meters should be 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 JI 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 spirolab ZII 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 strong 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 For any repairs call only certified service centres that are authorized by the manufacturer or directly call the manufacturer Do not open or tamper
81. rruption Temperature sensor Semiconductor 0 45 C Power supply Rechargeable battery Ni MH 6 elements 1 2V each 4000 mAh Batteries charger Output vonltage 12 V current 1 A compliant with EN 60601 1 Use exclusively battery charger provided from manufacturer MIR code 920665 Communication port interface RS232 bidirectional and optoisolated to 4KV Wireless Communication Bluetooth Dimensions 310x205x65mm Weight 1 9 kg Volume range 10L Flow range 16 L s Volume accuracy 396 or 50 mL Flow accuracy 596 or 200 mL s Dynamic resistance at 12 L s 0 5 cm H20 L s Type of electrical protection Class II device Safety level for shock hazard Type BF Apparatus Protection against water ingress IPXO Safety levels during use in presence of inflammable anaesthetic gases or oxygen or nitrogen Apparatus not suitable Conditions of use Apparatus for continuous use Conditions of storage Temperature MIN 20 C MAX 60 C spirolab ZIJ User Manual Code MIR 980067 REV 2 0 Page 16 74 Humidity MIN 10 RH MAX 95 RH Temperature MIN 10 C MAX 40 C Humidity MIN 10 RH MAX 95 RH Operating Conditions Electrical Safety Standard EN 60601 Applied ane ead Electro Magnetic Compatibility EN 60601 Life expectancy About 10 years Storing of parameters Flow Volume
82. rrupts 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 spirolab JJI User Manual Code MIR 980067 REV 2 0 Page 46 74 e measured values index predicted values x190 The interpretation of these indices according to the ATS standards generates a series of messages which correspond t
83. rticular use only original accessories and spare parts 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 when unplugging the device never pull the cable of the power supply or of the device spirolab 77 User Manual Code MIR 980067 REV 2 0 Page 9 74 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 the 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
84. ry and for the cardiac pulse are the same regardless of which of the above mentioned oximetry sensors is used 2 PRODUCT DESCRIPTION Spirolab 7 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 Spirolab 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 The main spirometric parameters are measured and displayed and all data with Flow Volume and Volume time curves can be printed out in seconds by the built in thermal printer The Flow Volume curve is shown in real time 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
85. spirolab HI User Manual User Manual Rev 2 0 04 04 2011 E Approved on 040420 NATIO AS Na T un 2 MIR wu T spirolab 7 77 User Manual Code MIR 980067 REV 2 0 Page 1 74 Thank you for choosing a product from MIR Medical International Research WARNING A The paper mouthpiece the nose clip and the disposable turbine with mouthpiece in the equipment should be considered disposable products WARNING A The oximetry function is not available for spirolab Ill with black and white display 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 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 the manufacturer therefore reserves the right to modify and to update the information 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 f
86. spirometry test with a e disposable turbine it is of vital importance to use a new 4 Nid turbine for each patient The characteristics accuracy and the DN hygiene of the disposable turbine can only be guaranteed if it Nd 4 has been conserved beforehand in its original sealed Disposable packaging The disposable turbine is made of plastic and its Turbine disposal after use must adhere to the local regulations and norms in force The correct functioning of the re usable turbine can only be 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 another Periodic cleaning should only be done when the instrument is for Reusable personal use and will only be used by one patient The Turbine cleaning of the turbine should be performed according to the instructions contained in the User s Manual For cleaning operations see S 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 t
87. ssed with pulse frequency lt 40 BPM__ hh mm ss T gt 120 BPM Time passed with pulse frequency gt 120 BPM hh mm ss Bradycar Events lt 40 Bradycardia events during the entire analysis BPM period Tachycar Events gt 120 Tachycardia events during the entire analysis BPM period Total Desat Events eae events during the entire analysis ODI Desaturation events per hour of analysis 1 h Mean Duration Average duration of desaturation events S Longest Duration Longest duration of desaturation events S Desaturation Peak Minimum Sp02 during desaturation events Mean Desaturation Average duration of desaturation events Mean Drop SpO2 Average SpO2 fall with respect to baseline during the desaturation events Maximum fall of SpO2 with respect of Max Drop SpO2 baseline during the desaturation events 7 N Pulse Variations Variation of pulse frequency events during the entire analysis period Pulse Index Variation of pulse frequency by hour of 4 h analysis Time passed with SpO2 lt 4 with respect to NOD 4 SpO2 base for continual periods above 5 V hh mm ss minutes gt 5 NOD 89 Time passed with SpO2 lt 89 for continued Ramee periods above 5 minutes spirolab ZIJ User Manual Code MIR 980067 REV 2 0 Page 19 74 SYMBOL DESCRIPTION Time passed with SpO2 lt 90 for continued
88. t the volume in cL of the calibration syringe in use e g for a 3L syringe insert 300 cL 2 Insert 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 spirolab ZIJ User Manual Code MIR 980067 REV 2 0 Page 31 74 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 ZZ 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
89. 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 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 A The instrument must be used as described in the User
90. the oximetry test spirolab 7 7 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 SpO oxygen saturation and blood pulse rate utilize the re usable finger sensor This sensor is recommended for patients weighing gt 20 Kg with limited activity spirolab ZIJ User Manual Code MIR 980067 REV 2 0 Page 47 74 spirolab JT memorises the two oximetry values every 2 or 4 seconds Carry out an oximetry test as follows e 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 press to access the test menu e Select required test using the vertical Scroll arrow If this message appears OXIMETRY NOT DETECTED then your instrument does not include an oximeter If this message appears
91. thod with then press qe From this display it is also possible make the archive transmission with Bluetooth connection using a cell phone please see paragraph 3 1 2 13 4 Subject List by last name This message appears INSERT LAST NAME OR THE FIRST spirolab ZIJ User Manual Code MIR 980067 REV 2 0 Page 54 74 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 to view related values Print selected test results using the internal printer by pressing s pressing twice 2 13 2 Subject List by ID code the data are print on the external printer via Bluetooth system The following message appears ENTER ID CODE OR PARTIAL TO SEARCH MATCHING FILES Enter subject ID and press to view the list containing all file linked with the patient The data can be printed like described previously 2 13 3 Memory List MEMORY LIST NAME DATE 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
92. ty 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 Z 7 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 Spirolab 77T 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 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 s
93. ty warnings sssseeeeee ener 8 1 2 1 Danger of cross contamination essere 11 1 2 2 TUDIN cum tee tem ec ee itis 11 1 2 3 Mouthpiece erento ede deinen reete Henr rece iine 11 1 2 4 Oximetry Sensor cine eR opc hates nma e n ge e Ra Pea ose AE ea A a inan 12 1 3 problems and unforseen errors sssseseeeeee emm enne 13 1 4 LABELS AND SYMBOLS sese em ener ennemis 14 1 5 techical features of the spirometer ssesssee em 16 1 6 technical specifications seniri niei e ip e ed ted 17 1 6 1 Features of the spirometer ssssseneem emm 17 1 6 2 Features of the oximeter 2 cccccceececceceseceeeeeeenetedeoeneenseeeeeensedereseoneenssstie 18 2 PRODUCT DESCRIPTION eee emm nennen nene n nennen nene en nennen nnne 22 2 1 ILLUSTRATION OF Spirolab III emen 24 2 2 Icy isole Lx 24 2 3 Charging the battery oet eren teni prora rto tte eL gen aie 25 24 Switching on the spirometer sssssseeeeen emm ene 26 2 5 NIME 26 2 5 1 Contrast settings oorr t one e i eee EE Rez ee perge 27 2 5 2 Loading the thermal paper ssssssssseeeeeeeeeneen enne 27 2 5 3 Connecting the flow Sensor eet ein iip idt ped dec 28 2 5 4 Switching off the spirometer ssssssseee emere 28 2 5 5 Initial settings eiit reete teneo deed cte rede teaa i atiae 29 2 5 6 Functioning of the spirometer
94. with the device Always use and demand only original spare parts For the recycling of the spirolab ZII 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 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 of the device and is therefore not permitted The installation must be carried out according to the manufacturer s instructions 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 pa
95. within 151 to 200 mL D only one acceptable manoeuvres or more than one but the FEV1 values not matching to within 200 mL with no interpretation F No acceptable manoeuvres with no interpretation POST Test A two acceptable 1 FEV1 values matching within 100 mL B two acceptable 1 FEV1 values matching within 200 mL C two acceptable 1 FEV1 values that do not match within 200 mL D only one acceptable 1 FEV1 manoeuvre F No acceptable 1 FEV1 manoeuvres Acceptable manoeuvre means good start and satisfactory exhalation duration and flow Where several comments related to the single test are calculated spirolab ZT will only show the most important to facilitate the test interpretation ERROR IN Vext and PEFT If the extrapolated volume Vext is greater than 500 mL or more than 5 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 FET ERROR If the FET is less than the 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 spirolab ZIJ User Manual Code MIR 980067 REV 2 0 Page 45 74 2 9 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
96. ystem consult the manufacturer or an authorized representative spirolab II 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 JJ User Manual Code MIR 980067 REV 2 0 Page 23 74 2 1 ILLUSTRATION OF SPIROLAB II MiniFlowmeter sensor Thermal paper container Flow sensor compartment Display Keyboard Oximeter sensor OO ON 2 2 KEYBOARD o ap ooo cea nn ca amp Soe oco oan co es amp C 39 co C O ez METTI m a SYMBOL DESCR

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