BTl-O8 Spiro Spiro Pro INSTRUCTION MANUALBTL-08 Spiro INSTRUCTION MANUAL ‘TABLE OF CONTENTS 1 BASIC CHARACTERISTIC OF THE DEVICE 4 2 PERFORMANCE OF THE SPIROMETRY TEST.... 5 24 Contraingications for spirometry 5 244 Absolute 5 242 Relative 5 22° Conditions that could markedly influence the result of measurement [1] 5 23 Recommended test sequence 5 2.4 Performance of forced spirometry tast 6 244 Inspiratory and expiratory forced spirometry 6 242 Expiratory forced spirometry S 25 Performance of relaxed splrometry test 10 3 _ INSTRUCTIONS FOR USE. . 34 Description of THE BTL- 08 Spiro 2 Bat ‘Keyboard and top panel of the device. 12 312 Rear panel of the Gevice 3 313 Pneumotachograph description 14 32 Device assembly and putting nto operation. 14 33 Function summary of keyboard buttons 18 331 start 18 332 accept 8 333 stop. 18 334 print 18 338 analyse 15 336 forced 8 337 relaxed. 18 338 mw. 16 338 profi. 18 3310 patient 16 3311 calibr 16 3312 child incentive. 16 3313 predict values 18 aid contrast. 6 3318 menu 16 33.18 p-arrowidovinarrow. 16 3317 ese 18 3318 enter 7 3319 onvoft 7 3.320 paper feeder (FF form feec) 7 3321 device reset 7 34 Printer and paper 7 341 Paper sensitivity 18 342 Roll paper with raster. 18 343 USB printar setup 18 3434 resolution (dp), 13 3432 printer test 19 344 Storing conditions of thermal-sensitive paper. 13 35 Storage battery 19 36 Lithium battery 20 4 COURSE OF EXAMINATION... A 44 Profle selection for collection of the spiro record, 21 42 Patient selection 21 43 Pneumotachograph interface 21 4.4 Recommended grasping of pneumstachagrach 22 45 Examination procedure 22 454 Examination in forced profile 23 4544 Inspiratory and expiratory forced spirometry (complete) 23 4512 Expiratory forced spirometry (expiratory) 24 452 Examination in relaxed profile 25 453 Examination in mvv profile. 27 48 BTPS correction 28 page 2 of 94BTL-08 Spiro INSTRUCTION MANUAL 4g. ATP conversion into 8TPS 28 482 Measurement rellablty and INTERPRETATION 28 463 Measurement resuits and their acceptance (FVC measurement) 23 5 SETUP MODE. .onnnnnmnninnininnineininninnninnnmnnnninnnmmnnnnnnnnmnennmnannnsnn St 5A Main menu 34 Bit Records fie a 512 Profile setup 31 5124 Forced, relaxed and mvy profile properties setup 32 513 Calibration 32 514 Device setup. 3 BA4a ‘Starting profile — selection of profile ater stat. 5442 Line wicth, 33 5143 Medical record of the patient-patient's record setup 3 5144 ‘Optional specifications of the patient 33 5148 Paper and print setup, 34 514s Module information 34 S147 User setup 34 SA47.41 Time and date 34 B1472 Display contrast. 34 BA473 Language options, 34 S1474 ‘Touch screen calibration 34 BAATS Files correction 34 S1476 Files system format 34 51477 Default setting without data loss. 34 51478 Device sleep mode interval 34 1479 Battery level indicator 35 8147.10 More. 35 518 Patient selection 35 516 Doctor selection. 35 6 ACCESSORIES. 36 7 MAINTENACE AND DEVICE SAFETY.. 37 77 Cleaning the device surface and its parts, 37 Tat ‘Cleaning the touch screen. 37 712 Cleaning the paper sensors. a7 72 Hygiene, cleaning and disinfection of spirometric accessones in contact with the patient 38 724 Hygiene. 38 722 Cleaning 38 723 Disinfection 38 724 Sterlization 40 73 Device safety 40 74 Conditions of guarantee. 41 8 TECHNICAL SPECIFICATIONS. : a1 Legend of the measurement parameters 44 Bit Forced spirometry 44 812 Relaxed spirometry 46 813 ‘Measuring of the maximum pulmonary ventiation volume 46 82 Predictive values. a7 83 —_ Relevant standard specifications and recommendations 48 84 ——Ustof literature 48 85 Manufacturer. 50 88 Sale and service 80 BTL CUSTOMER CARD page 9 of 54BTL-08 Spiro INSTRUCTION MANUAL 1 BASIC CHARACTERISTIC OF THE DEVICE ‘The BTL-08 Spiro is a moder device for the basic and certain additional (e.g. post-mecical) spirometric examination It provides a detailed analysis, automatic interpretation and print of spirometric curves. it exceeds in a wide range of teatures and transparent operating, which can be easily and quickly developed by anybody. The device enables users to simply adjust standard values (predictive values), methodically choose up to 15 parameters for the actual measurement, start the automatic interpretation of forced! spirometry or e.g. to define @ record of bronchoprovecative: tests ‘The BTL0B Spiro device is equipped with a graphic high-resolution display and allows viewing flowevolume and vvolume-time graphics in real time. Large-sereen colour display excels in qualty pictures and itis equipped with touch sereen buttons, ‘The BTL-08 Spiro is fitted with sensors for measuring room temperature, barometric pressure and relative humidity ‘Therefore it can carry out the automatic correction of parameters to BTPS conditions. ‘The BTL-08 Spiro has an integrated 112 mm wie printer that can print on A6 format, Thereby all spiro graphics can be printed together with the measured values. ‘The BTL-08 Spiro has implemented patient records and a file of particular measurements, enabling to register and store up to 260 records of all measurements in the memory and simply print them by an internal (thermal) printer or more comfortably by an external printer connected through USB. ‘The BTL-08 Spiro is fited with storage batteries that make the device fully portable, so it Is not limited to use it only in fa doctors surgery. Massurements can start immediately after the davice is switched on, however itis necessary to set Up the patients personal data before that eventually choose from the patient records. ‘The BTL-08 Spiro Is developed according to the latest Knowledge and recommendations and meets the ATS / ERS 12006 references and European standards for spirometers EN 13826. Pheumotachogragh for the BTL-08 Spiro can be bought separately and may be connected as an additional device to ECG series BTL-08 ECG — type SD, MT Plus, LT. LT Plus, LC and LC Plus. ‘The latest information on BTL products and contact for the BTL companies can be always found on the Intemet adress http://wenw.btl.cz, eventually on httpi/lwww.btinet.com. page 4 of 54BTL-08 Spiro INSTRUCTION MANUAL 2 PERFORMANCE OF THE SPIROMETRY TEST 2.1 CONTRAINDICATIONS FOR SPIROMETRY ‘The list of contraindications tells us, when the manufacturer does not recommend to apply a chosen therapy. Clearly, specialized branches, that are aware of possible resulting consequences, do not need to observe these featured contrainaications. However, all liabilty for such usage rests upon the specialized stations. 2.1.1 Absolute postoperative conditions after chest operation ‘month after myocardial infarction serious instability of air passages ~ emphysema bronchial non-specifcally marked hypersensitiveness serious difficulties during gas exchange - total or partial respiratory insufficiency 2.1.2Relative ‘spontaneous condition after pneumothorax arterlal- venous aneurysm ‘severe arterial hypertension pregnancy with complications in 3ré month pro test in MW profile: hyperventilation syndrome 2.2 CONDITIONS THAT COULD MARKEDLY INFLUENCE THE RESULT OF MEASUREMENT [1] strong, unpleasant pulmonary pain or stomach-ache strong, unpleasant pain in mouth or face stress incontinence dementia or mental disorder ‘smoking 1 hour and less before the examination alcohol consumption 4 hours and less before the examination tiring activity (e.g. exhausting training) 30 minutes and less before the examination satiety / consumption of bigger meal 2 hours and less before the examination firm, tight clothing, that can influence maximal breath tidiness of spirometric sensor - always keep the sensor and measuring mesh clean and absolutely dry Inserted slicone seal between spirometric sensor and pneumotachograph - without Its presence itis not possible to measure any curve or calbrate the sensor! 2.3 RECOMMENDED TEST SEQUENCE forced spirometry - FVO, PEF relaxed spirometry ~ SVC, MV ‘medicine inhalation (if used) repeating of forced spirometry — post-madical examination page 9 of 54BTL-08 Spiro INSTRUCTION MANUAL 2.4 PERFORMANCE OF FORCED SPIROMETRY TEST ‘This is an examination, when the display shows a graphic chart for complete expiratory and inspiratory loop = flow [FI / volume [V] = volume [V]/ time (i (only expiratory part of the curve) ~ and eventually a motivational picture for chiloren Course of examinetion scheme. ‘SWITCH ON device on/off - CHOOSE PROFILE (FORCED) - ENTER PATIENT'S DATA - START COLLECTION ‘start button ~ AUTOMATIC FINISH. Before starting the record, check or adjust and set these parameters — they cannot be changed during record ‘clean and absolutely dry the spirometric sensor and measuring mesh required profile clinical parameters (spiro parameters) ‘selection of the tast type (bronchodilator, bronchoconstrictor test) type of dosage choice of inspiratory and expiratory forced spirometry (complet ) | expiratory forced spirometry (expiratory) ‘The examination will be automatically finished after the time (set in profile) is up, it can be also stopped at any time by the stop key. If tne actual measuring is accepted, confirm it by pressing tne accept button. Press the print keys. The device will start printing results ofthe gained values during measuring on thermal paper. Measurements are automatically stored in the record files! Evaluation of both tests: ‘The basic examination ends with the acceptance of three procedures. Then a table is displayed next to three valid procedures (graphics) in the flowivolume graphic chart: the table includes measured values FEV’, FVC and PEF compared with the presictive values for Individual procedures. At the same time the programme highlights the best curve. You can manually choose a cifferent curve by clicking an appropriate procedure in the displayed table. At the same time there Is reproduciblity of FEV1, FVC and PEF parameters displayed (e.g. FVC+ means that FVC is reproducible, FVC- means that it s not reproducible. 2.4.1 Inspiratory and expiratory forced spirometry + Switch the device on by pressing the on off button. + Choose the printing record profile - menu ~ profile setup — forced and follow the instructions on the display of the device. Examination includes a completion of at least three correct (accepted) measurements (procedures). ‘+ Enter the patients name and date (date of birth, sex, weight, height and race); this will be used for the calculation of the predictive values and for the record analysis - press the patient button + Check the cleanness of spirometric sensor and measuring mesh ‘+ Intiation ofthe signal collection will start by pressing the start button. + Ask the patient to breathe calmly and maximally into the pneumetachograph and straight after that to do a ‘maximally forced aspiration and maximally forced expiration - and at the same time encourage the patient by saying "more and more" and "even deeper" In stages of maximum asplration and expiration ‘+The collection finishes automatically after a lapse of exact time in a certain profile (see examination in set profiles) ‘or by pressing the stop button + Right after the frst achieved procedure, the accept button vill occur on the bottom line of the touch screen. You will accept the measurements as correct By pressing this button and then continue with collection by pressing start. + Avview of the records trom ofthe first procedure can be obtained by the analyse button (displayed on the bottom line of the touch screen - after pressing the accept button), this view will show you the already measured resulis and values of the spirometric curve. page 0 of 54BTL-08 Spiro INSTRUCTION MANUAL WARNING! This is @ premature termination of the examination, and itis impossible to continue further measuring after that. + The BTL-08 Spiro will save results from three consecutive collections. I there are three correct measurements received (by the accept button) - then the results from the measurements will be displayed on the screen, and the device will accomplish automatic selection of the Oast curves according to the criteria FEV + FVC in forced. profile, The buttons start and accept will appear atthe end! of each procedure. In the case of an unsuccessful measurement carry out the collection again by pressing the start button, the results of the last measurement will be automatically iscarded, In situation the test was accomplished correctly, choose accept and continue in measuring the next procedure, We recommend accomplishing 3 consecutive measurements for a correct comparison of the results. page 7 of 94BTL-08 Spiro INSTRUCTION MANUAL 2.4.2Expiratory forced spirometry ‘+ Switch the device on by pressing onvoff. ‘+ Choose printing record profle - menu ~ profile setup - forced and follow the instructions on the display of the device, The examination includes a completion of at least three correct (accepted) measurements (procedures) + Enter the patient's name and date (date of birth, sex, weight, height and race); this will be used for the calculation Of the predictive values and for the record analysis - press the patient bution ‘+ Chack the cleanness of spirometric sensor and measuring mesh. ‘+The initiation ofthe signal collection wil start by pressing the start button. ‘+ Ask the patient to maximally forcefully inspire (aside the spirometric module), immediately after that enclose the ‘mouthpiece of the spirometer in his lips and maximally narrowly breathe into the spirometric module. Encourage YyoUr patient during his maximal expiration by saying "more and more” and "even deeper”. We racommend using a nose clip. ‘+ Tne collection finishes automatically after a lapse of exact time in a certain profile (see examination in set profes) ‘or by pressing the stop button ‘+ Right after the frst achieved procedure, the accept button wil occur on the bottom line of the touch screen. You will accept the measurements as correct by pressing this button and then continue with collection by pressing start + A view of the records trom ofthe first procedure can be obtained by the analyse button (displayed on the bottom line of the touch screen - after pressing the accept button). this view will show you the already measured results and values of the spirometric curve. WARNING! This is @ premature termination of the examination, and it's Impossible to continue further measuring after that. + The BTL-08 Spiro will save the results after three consecutive collections. If there are three correct measurements. received (by the accept button) - then the results from the measurements will be displayed on the screen, and the device will accomplish an automatic selection of the best curves according to the criteria FEV1 + FVC in forced protie. ‘The buttons start and accept will appear et the end of each procedure. In the case of an unsuccessful measurement, carry out the collection again by pressing the start button, the resuits of the last measurement will be automatically ciscarded, ifthe test was accomplished correctly, cnoose accept and continue in measuring the naxt procedure. We recommend accomplishing 3 consecutive measurements for a correct comparison of the results. page ® of 94BTL-08 Spiro INSTRUCTION MANUAL page 9 of 54BTL-08 Spiro INSTRUCTION MANUAL 2.5 PERFORMANCE OF RELAXED SPIROMETRY TEST ‘An examination in relaxed profile will test changing volume of lungs at the beginning of relaxed expiration — when the lungs are completely fled, to the end of expiration - when the lungs contain only a residual volume and conversely Course of examination scheme ‘SWITCH ON device on/off - CHOOSE PROFILE (RELAXED) - ENTER PATIENT'S DATA ~ START COLLECTION ‘start button — AUTOMATIC FINISH. Before starting the record, check or aojust and set these parameters ~ they cannot be changed during the record: + clean and absolutely dry the splrometric sensor and measuring mesh + clinical parameters (spiro parameters) + required profile Examination will be automatically finished after the time (set in profile) Is up, it can be also stopped any time by the stop key. ifthe actual measuring is accepted, confirm it by pressing the accept button Press the print key. The device wil start printing the results of the gained values during measuring on thermal paper. Measurements are automatically stored in record fest ‘+ Switch the daviee on by pressing onioff. + Choose the printing record profile ~ menu - profile setup ~ relaxed and follow the instructions on the display of the device. The examination includes the completion of at least three correct (accepted) measurements (procedures) ‘+ Enter the patients name and date (date of birth, sex, weight, height and race); this will be used for the calculation of the predictive values and for the record analysis - press the patient button + Ask your patient to grip the mouthpiece firmly in his lips and breathe calmly, tell him to perform @ maximal deep expiration witnout major effort until all the air Is emptied trom the lungs, and then slowly breathe untl the ‘maximum aspiration (s0 - called EVC procedure) and ask him again to perform everything conversely (s0 - called IVC procedure), + Check the cleanness of spirometric sensor and measuring mesh. ‘+ The initiation of the signal collection wil start by pressing the start button, + The patient breathes composedly. When the curve crosses the vertical cashed line (6 seconds from the start of ‘measuring). ask the patient to perform the EVC procedure (deep expiration and then slow deep aspiration to the maximum) and after a short relaxed breathing (about 3 to $ cycles) ask your patient to perform the IVC procedure (deep aspiration and then seep expiration until all air is out of lungs). The patient should accomplish both these procedures within 30 seconds — itis on the display marked by space between vertical dashed lines, The patient can continue with relaxed breathing, measuring is finished. ‘+The collection finishes automatically after a lapse of exact time in a certain profile (see examination in set profes) co by pressing the stop button + Right after the frst achieved procedure, the accept button wil occur on the bottom line of the touch screen. You will accept the measurements as correct by pressing this button anc then continue with collection by pressing start ‘+ A\view of the records from ofthe first procedure can be obtained by the analyse button (displayed on the bottom line of the touch screen - after pressing the accept button), this view will snow you the already measured results land values of the spirometric curve. WARNING! This is @ premature termination of the examination, and it's Impossible to continue further measuring after that. + The BTL.08 Spiro will save and compare the results after three consecutive collections. If there are three correct measurements received (by the accept button) ~ then the results from the measurements will be displayed on the screen, and the device will accomplish an automatic selection of the best curves accorting to the criteria SVC in relaxed profie, page 10 of 81BTL-08 Spiro INSTRUCTION MANUAL To finish the measurements, the stop button wil appear during each procedure. In case of an unsuccessful measurement carry out the collection again by pressing the start button, if the test was accomplished correctly choose accept and continue with measurements. WARNING! Patients with COLD (Chronic Obstructive Lung Disease) can take a longer time to breathe out and may taint. During and after the measurements, there are SVC, ERV. IRV and TV values displayed on the screen along with volume [V] time curve. All procedures are shown on the display, including a graphic chart of slow vital capacity for the best performed! aspiration / expiration of the current patient, compared with a Selected predictive value, page tt of otBTL-08 Spiro INSTRUCTION MANUAL 3 INSTRUCTIONS FOR USE 3.1 DESCRIPTION OF THE BTL- 08 SPIRO 3.1.1Keyboard and top panel of the device page 12 of otBTL-08 Spiro INSTRUCTION MANUAL Description of individual keys see chapter Function summary of keyboards buttons printer cover detent lever for the printer head colour touch screen battery level indicator (batt) ‘switch - on indicator (power) storage battery charging incicator (charge) discharged storage battery incicator (low batt) printer error indicator (printer) Connector for patient ECG cable (possibilty to extend the spirometry for ECG module) part of the keyboard to operate the printer part of the keyboard for setting racord characteristics pneumotachograph ergonomic spirometer holder 3.1.2Rear panel of the device 14, 18, 6 17, 18. 19, 20 21 segeoy, § ald be device switch ~ postion 0 and! connector for feeder cable connection communication connector CS 232 to connect pneumotachograph communication connector USB to connect personal computer (PC) or external printer line fuse ‘manufacturing and type plate (placed on bottom cover of the device) mains voltage switeh RESET button, programme restart in case the device does not respond to pressing any key clamp for device shielding (itis placed on the bottom cover of the device, only with the shouldered ECG modula) page 13 of 81BTL-08 Spiro INSTRUCTION MANUAL 3.1.3Pneumotachograph description Description of the parts: 23, = plastic mouthpiece (can be replaced by paper mouthpiece) 24 ~spirometric sensor 25. — button to release spirometric sensor 26. — pnemotachograph 27. =Slicone seal 3.2 DEVICE ASSEMBLY AND PUTTING INTO OPERATION Unpack the device trom the wrapping and place it on a firm fat surface, large enough to support the weight of the. device. Do nat expose the device to the direct rays of the sun, The device heats up during operation therefore it must not be placed near equipment that can heat up or generate heat. You must net place any objects producing heat on the device, or objects containing water, or any other liquid, Do net place the device near equipment producing a strong electromagnetic, electric, or magnetic field (diathermy, X - rays etc.) It could affect the operation of the device. In adaition the recording paper, which is heat- sensitive, should be placed out of reach of thermal radiators (including irect sunlight) see chapter Storing conditions of thermal-sensitive paper. In case of any doubts contact the authorised service of BTL equipment ‘The BTLOB spiro devies is cooled by natural and compulsory alr circulation. The cooling openings are placed under the device and around the printer. and must not be covered. Therefore do not put the device on a soft surface, so as Not to cover or limit the ar circulation to the lower cooling openings. We recommend that you keep the device packaging for eventual further transpor of the device. Plug the device directly into the power mains supply; do not use extension cord with multiple connections or the adaptor. page 14 of 81BTL-08 Spiro INSTRUCTION MANUAL ‘Switching the device on: lug the power cord into the socket, switch toggle switch (see No.14 In chapter Rear panel of the device on the rear isplay) marked O/ | to position | and finally press the on/off switch on the keyboard, The switch - on inclcator (6) vill light up. Do net leave the power suitch of the device (14) in postion I, In order to charge the storage batteries, y cherai ‘The device contains an internal storage battery, which is supplied in a semi - charged state, Therefore, after the Gevice Is purchased, we recommend to accomplish formatting the storage battery, .e. to plug the device into the Power mains supply with the toggle switch (14) in position I, for at least 48 hours non-stop. The device vill be charged up and storage battery willbe correctly formated and recharged to the maximum level. A correctly formatted storage battery allows long-term operation of the davies on one charge. For further information see Storage battery. 3.3 FUNCTION SUMMARY OF KEYBOARD BUTTONS ‘Touch screen butions, if displayed, provide the same functions as the buttons on the keyboard. The touch screen buttons can be pressed by the finger or by a special pointer with a soft tip, so - called touch screen pen pointer, which is a part of the standard accessories of the device. WARNING! The touch panel must not get into contact with any sharp instruments, ballpoint pen, etc. 3.3.1start It is used to start the beginning of data collection for particular measurements. It is always necessary to enter all the important information about the patient before the initiation of the collection (see. menu - patient selection) otherwise it will not be possible to perform the whole measuring 3.3.2accept Pressing the accept button confims acceptance of the collected data of particular measurements, i the collection is. Unsatisfactory, press the start button again. 3.3.3stop ‘This button Is used to Interrupt printing in progress. If the device Is engaged with e.g. analysis. or measuring spirometric curves, the reaction of pressing the stop button can be delayed. In such cases walt, unt the device finishes the performed operation and press the button again 3.3.4 print ‘A report of the completed metering or measurement chosen from the database can be printed out by pressing this button; otherwise the collection will be saved in the memory of the device in the pre - set profil, Ifthe daviee is engaged with e.g. analysis, or measuring spirometric curves, the reaction to pressing the print button can be delayed. In such cases walt unt the device fnishes the performed operation ~ the report "working ... will stop showing on dispiay - and press the button again, 3.3.5analyse Press this button to dlgplay the rasult of the analysis of the last collaction. At the same time it is used to abort the ‘examination of the patient ~ by pressing the button, the measuring wil finish and itis not possible to continue the measurements again 3.3.6forced By pressing the forced button you will confirm the selection of data collection in the forced profile. 3.3.Trelaxed By pressing the relaxed button you will confirm the selection of data collection i relaxed profile, page 18 of 81BTL-08 Spiro INSTRUCTION MANUAL 3.3.8mvv By pressing the mwv button you will confirm the selection of data collection in the mvv profi. 3.3.9 profile Choose one of the possible user-profiles that can be modified in the profile setup. The selection cyclically rotates over the actual profiles. The collection starts according to parameters preset in the memory of the device, The choice of an actual regime is indicated at the bottom status line of the display. Certain profiles can be selected also with the touch sereen buttons directly on the display. Touch the screen in any place and the top and bottom toolbars with the control buttons will come up on the display. Pressing the touch screen, ‘the profile button will show you the menu with the choice of all possible profies in the device. 3.3.10 patient ‘This button is used to activate the dialog box for entering data about a new patiant. The data is saved by pressing ‘enter. This data is printed in the record, at the same time saved in the device's memory together with the collection, and can be selected from patients’ fle (see menu - select patient), where you cen view them and eventually print them out on recording paper. Select the type of data from the menu that can be modified (filed in and saved), ¢.g. - device setup - patient record setup. 3.3.11 calibr Press the calibr button and enter calibration records submenu or use calib, button at the right bottom status bar on the display. Further selection in the calibration records submenu is controlled by the touch screen. There is possible to Perform calibration or calibration verification. For detailed description of all calibration functions please see chapter Calibration. 3.3.12 child incentive This is used to svitch the stimulation on/off to motivate children during examination in the forced profi. A chosen picture is displayed on the right half ofthe screen. For the setup see menu — profile setup. 3.3.19 predict values Enter to select the system of spirometry predictive values — resulting from the choice of expected values (eg. Knudson, Roca, ECCS etc.) 3.3.14 contrast @ ‘The button is used to set up the contrast quickly of the display. The contrast can also be changed at the device setup menu, Change of contrast of the colour display can modify the actual colour scheme, 3.3.15 menu ‘This button is used to enter the menu that includes the device setup, patients' data service ete. To enter the menu you can also use the touch screen. Touch the sereen at any place and the top and bottom toolbars. with the control buttons will come up on the isplay. Press the touch screen menu button (right bottom corner) or press the button on the keyboard and the device menu will appear 3.3.16 up ‘These buttons are used to move the menu and eventually o change the values. The touch screen buttons, it cisplayed, provide the same functions as on the keyboard, rrow/down-arrow 3.3.17 ese This button is used to cancel the choice or to retum to a higher dialog box in the menu without saving the entered values. The touch screen bution, ifcisplayed, is used the same way as on the keyboard, page 16 of 51BTL-08 Spiro INSTRUCTION MANUAL 3.3.18 enter ‘The button Is used to confirm the selection and saving the values or to enter the lower dialog box of the menu. The touch screen button, if displayed, provides the same function as on the keyooard, 3.3.19 on/off ‘The button Is used to switch the device on and off, When suitching off, the device monitors the state of the storage batteries; ifthe batteries are discharged, the device will switcn into charging mode, with power and charge indicators fon. When the storage battery Is recharged, the device will automatically switch off completely. This applies only if the device is plugged into the power mains and the toggle switch (14) on the rear panel is in position |. if t is not connected, or the switch (14) Is in position 0, the device will switen off completely, Note It may take some time to recognize the condition of the storage battery; therefore the device certain delay when switched off and immeciately switched on again, All the saved data of the device is kept in the memory even during power shutdown. n respond with a 3.3.20 paper feeder (FF - form feed) ‘This button is available only on the touch screen. Touch the screen on any place and the top and bottom toolbar with the control buttons will appear on the display. The FF button , form feed .is in the left bottom corner. Press the button and the paper will come out of the printer. Depending on the type of paper, it wil move out to the next page (z-fold Paper), or about 2cm out (roll - paper). It is possible to press the button repeatedly. For more information on manipulation witn the paper, see chapter Printer and paper. 3.9.24 device reset Ifthe device for some reason (electromagnetic disturbance etc.) stops responding to the users instructions (keyboard, touch panel) and there is no ‘walt please’ sign with moving squares, then It's possible to put the device Into an intial slate by oressing the reset button (18) on rear panel of the device. After this action the device will restart immediately ‘Then itis possible the carry working with the device. Note It the device is in this state (Ie. “no response’) the button on / off maifunctions too. The only help is to press the reset, see above. 3.4 PRINTER AND PAPER ‘The printer uses thermal - sensitive paper for the record. The paper quality can significantly influence the quality of print. For @ high - quality record we advise to use only paper recommended by the BTL Company. ‘The yellow indicator (8) displays an error condition, which occurred in the printer. It can be caused by: + missing paper ‘+ faulty pressure of the printer head on the paper ( detent lever of the printer head (2) isin the unlocked position: by turning the detent lever leftwards, the head will lock and will be ready for printing). + inaccurately closed printer cover, the use of unsultable paper type or setup of inadequate paper type. Error message with adiltional information is displayed en the screen together with the Indicator. ‘Another possible way of printing Is the connection of an external printer through a USB interface. The USB connector is located on the rear panel (17) and it is designed to connect the PC andlor printers. Detalled description of the printer selection, see below page 17 of 81BTL-08 Spiro INSTRUCTION MANUAL 3.4.1Paper sensitivity Every paper type is slightly different. depending on sensftvity to thermal impulses produced by the printer. The final print can be too light and illegiole, or opposite too dark, almost burnt (it's cisplayed as white centre Inside the printed line). For these reasons, the device allows It to adapt to different paper types. Paper sensitivity can be set in the menu ~ device setup - paper and print setup, at the entry paper sensitivity. The more sensitive paper is set, the lighter the print willbe in the end, There are & sensitivity setupe available altogether. The best is to always try @ suitable setup on 2 couple of prints when changing the paper type. 3.4.2Roll paper with raster ‘The device can print on thermal - sensitive roll paper with raster of 112 mm nominal wieth (see. chapter Technical specifications). For a high - quality cecord we recommend to use paper supplied by BTL companies only Paper Insertion: Remove the printer cover (1), move the detent lever (2) to the right, insert the paper into the paper container and place in front of the printer roller. Insert the end of the recording paper under the guide rolier and the printer mechanism will start to draw the paper in automatically. Close the paper container cover and return the detent lever left. Crooked or an unevenly tom end of the inserting paper can obstruct automatic pulling of the paper. or the detent lever position ~ must be completely to the right ~ ofthe ened. ‘The paper feeder button, or the next page shift (FF ~ form feed) is available also on the touch screen in left bottom corner. By pressing this button, the paper can be released eny time from the device. ‘Tearing the paper: We recommend to tearing the roll paper away by pulling t irectly from the bottom paper margin across the tear - off edge towards the display, ATTENTION It is absolutely essential to fold and insert the new paper very carefully and exactly parallel with the tear - off ‘edge (raster on paper must be exactly in parallel with the tear - off edge); otherwise the paper will descend ‘sidelong during unwinding, or will crush inside and tear. 3.4.3USB printer setup Pressing the USB printer setup bution wil open the dialog box for the printer selection, which includes following ‘entries: print resolution for printers connected through USB - resolution (dpl), the button for printing a test copy on ‘the printar connected through USS - printer test and information on a printer currently connected to the device. ‘The description of currently connected USB equipment includes: the equipment manufacturer, supported languages, avaliable memory or maximum resolution supported by the printer. In some cases, this information can be inaccessible, eg. if the printer connected to the device is not supported or ‘equipment (other than a printer) is connected to the device. ‘The maximum recommended length of a USB cable Is 1,5 m, Printer requirements: + Interface USBI.1 er USB2.0 + POLS language + compatible with HP DeskJet or LaserJet ATTENTION ‘Some printers, that are not fully compatible with USB standard, may not be recognized by the device and can cause slow data transmission through USB. This current version does not support the printer model HP LJ 1022. Actual information on compatible printers is available at your BTL device supplier. page 18 of 81BTL-08 Spiro INSTRUCTION MANUAL 3.4.3.4 resolution (dpi) ‘This item Is used to change the resolution applied in USB printer. We recommend 200 dpi for faster print. Resolution 300 dp is intended for high - quality printing, Print a test copy to find the sultable resolution for your printer. 3.4.3.2 printer test Only the USB printer can print a test copy for detection of correct interface and setup. ‘The tast page Includes: dimensions to find corract resolution, used resolution, description of the USB printer and a ‘Gescription of the device Compare the actual measurements of the printing area with the dimensions printed on the paper and find out, if the selected resolution was correct 3.4.4Storing conditions of thermal-sensitive paper ‘The device prints on thermal - sensitive paper. To achieve the longest time stabilty of the printed record, itis absolutely necessary to keep the following conditions for storing the new and the printed paper: + storage temperature 25°C and lower relative humidity 65% and lower {do not expase the paper to the sunlight 0 not expose the paper to long - term radiation of fluorescent sources (fluorescent tubes etc.) prevent the paper from contact with alcohol based glue (or esters, Ketones eic). Use only starch, PVA or CMC based dispersive glue, ‘+ prevent the paper from any direct contact with PVC packing material, This packing contains material based on ‘esters that can damage the thermal - sensitive coat of he paper and cause disappearance of the record. 3.8 STORAGE BATTERY ‘The type of the storage battery is mentioned in chapter Technical specifications. An authorised customer service of the BTL device provides replacement of the battery. ‘The storage battery is continuously recharged during the operation of the device from the power mains. Charging and maintenance of the battery In the charged condition Is also In progress when the device is switched off, but it is connected to the power mains and power switch (14) on the rear panel in position |. When switching off. the davice checks the charging condition of the storage battery and ifthe battery is discharged, then the device will be turned into charging regime, the display will be switched off and the power and charge indicators will be on, see chapter Keyboard and the top panel of the device. When the storage battery Is recharged, the device will automatically switch off completely. This applies only if the device is plugged in the power mains and the toggle switch (14) on the. rear panel isin position | Finding out the condition of the storage battery lasts a while, therefore the device can respond with a certain delay ‘uring switching-off and immediately switching-on again, Complete storage battery recharge is achieved after about 6- hour charging — preferably overnight. ‘The discharged storage battery Is indicated by two signalling levels. + > the storage battery is almost discharged, but it can stil briefly print - the low batt indicator (7) lashes + the storage battery Is discharged, the device disables the printer to print — the low batt indicator (7) lights up permanently and at the same time the device makes a warning signal (short intermittent bleep 1x about every 20 ‘seconds). The audible alarm can be turned off, see chapter Battery level indicator. Itls possible, that the device will not be able to print the whole spirometric record, if the storage battery discharge: condition is indicated. Printing can be interrupted during the collection of data, Nevertheless the data is saved in the ‘device memory and can be printed after the storage battery is recharged. To extend the effective life of the storage battery, we recommend keeping It permanently charged. At any chance, connect the spirometer to the power mains and turn the power switch (14) to the position |. The indicator (6) will switch on and will switch off when recharged, and the storage battery willbe automatically maintained in a charged condition. page 18 of 51BTL-08 Spiro INSTRUCTION MANUAL Ifthe device Is disconnected from the mains or isin the switched off position for a longer time, then the storage battery (gradually and spontaneously discharges. This effect is a characteristic of the applied storage battery and cannot be Temoved, therefore If the device was switched off and disconnected for more than about 2 - 3 months, we advise to recharge the device, preferably 48 hours non-stop. For the same reason we recommend to charge the device immediately after purchase, continuously for at least 48, hours regardless of the storage battery level incicator (you can use the device as normal, except do not unplug the device from the power mains, the storage battery is charged up even during standard operation of the device). The storage battery will format itself and the device will ast longer in operation during one recharge. 3.6 LITHIUM BATTERY ‘The device includes a lithium battery for date and time backup. The type of the battery is mentioned in chapter Technical specifications. Replacement of the battery is provided by an authorised customer service of the BTL. device. page 20 of 81BTL-08 Spiro INSTRUCTION MANUAL 4 COURSE OF EXAMINATION When svitched-on, the device will start in the preset profile, It is possible to set the profile in menu ~ profile setup. Default profile forced is preset by the manufacturer. Therefore, the graph of full expiratory and inspiratory loop - flow [F]/ volume [V] and the graph of expiratory curve - volume [V|/ time [t] wil come up on display, The device is reacy Tor direct data collection. The display also shows these buttons and information: menu star ‘selected printing profile FF (form feed) 4.1 PROFILE SELECTION FOR COLLECTION OF THE SPIRO RECORD ‘The profes are used for fast setup of the device and its instant preparation for measuring. There are preset ‘specifications of the collection and the printer configuration. Parameters of the basic profiles are preset oy the manufacturer. Profiles can be changed in the menu of the device as needed, or before each examination, but not ‘uring measuring. Performed changes can also be saved in the memory of the device. ‘The device has 3 predefined basic profiles. ‘The forced profile is used for examination of a forced vital capacity, relaxed profile for a slow vital capacity and mwv profile for maximum voluntary ventilation. Apart from these three profile, itis possibie to create and also set other profiles (their selection is cyclic by pressing the profile button) ‘The collection of spirometric examination starts by pressing the start button. The collection finishes automatically after a lapse of time set in the profile, or by pressing the stop button, Depending on the set profle, the device can stl be completing the data collection for some time, a circle with ‘working ..." sign Is displayed on the screen. At this moment the device performs the analysis of recorded measurements and savas it in the memory of the devi 4.2 PATIENT SELECTION During and at the end of the examination, the measured records are compared with the presumed values that depend con some specifications of the patient ~ e.g. age, sex etc. ‘The patient can 0 chosen from the patients’ database or a new entry can be inserted (se menu — patient selection). The folowing minimum data about the patient Is required to count the predictive values and the analysis. of the spirometric curve: name, surname or ID, date of birth, sex and height, ‘To specity the height of e.g, handicapped peopl, It's possible to also use the length oftheir arms (arm span). 4.3 PNEUMOTACHOGRAPH INTERFACE Before the actual examination, you must insert the patient's part of the spirometry - pneumotachograph with the Soirometrie sensor and the mouthpiece to the connector (16) on the rear panel of the device, The connector is merked as RS232. page 21 of 81BTL-08 Spiro INSTRUCTION MANUAL 4.4 RECOMMENDED GRASPING OF PNEUMOTACHOGRAPH ‘The patient should sit comfortably throughout the tast to avoid chest pressing. Patient's head snould stay in upright postion, slightly bent forwards to do not close respiratory pipes. It is recommended to hold pneumotachograph throughout the test at horizontal position to avold contamination of measuring mesh and spirometric sensor by the patient's saliva, Patient's lips must hold the splrometer mouthplece on the outside and seize it with teeth, 4.5 EXAMINATION PROCEDURE ‘+ Switch the deviee on by pressing on /off button. ‘+ Choose the printing record profile ~ manu ~ profile setup ~ forced (relaxed or mwy) and follow the instructions fon the display of the device, The examination includes the completion of at least three correct (accepted) ‘measurements (procedures), ‘+ Enter the patients name and date (date of birth, sex, weight, height and race); this will be used for the calculation of the predictive values and for the record analysis - press the patient button + Check the cleanness of spirometrc sensor and measuring wire-gauze. ‘+ Intiation of the signal collection will start by pressing the start button. + The collection finishes automatically after an exact lapse of time in a certain profile (if activated - see examination In set profiles) or by pressing the stop button. + Directly after the first achieved procedure, the accept bution will appear on the bottom line of the touch screen. ‘You will accept the measurements as correct by pressing this bution and then continue with the collection by pressing start + Avview of the records from the frst procedure can be obtained by the analyse button (displayed on the bottom line of the touch screen - after pressing the accept button), this view will show you the current measured results, and values of the spirometric curve, WARNING! This is a premature termination of the examination, and itis Impossible to continue further measuring after that. + The BTL: 08 Spiro will save the results from three consecutive collections. If there are three correct, ‘measurements received (by the accept button) - then the results from the measurements will be dleplayed on the screen, and the device will accomplish an automatic selection of the best curves according to the criteria FEV! + FVC iin the forced profile, according to the criteria SVC in the relaxed profile and according to the mvy erteria in the mwy profile, page 22 of 81BTL-08 Spiro INSTRUCTION MANUAL 4.5.1Examination in forced protile ‘This is an examination, when the display shows a graphic chart for the complete expiratory and ingpiratory loop’ = flow [FI / volume [V] = volume [V]/ time (i (only expiratory part of the curve) ~ and eventually a motivational picture for chiloren Course of examination scheme. ‘SWITCH ON device on/off - CHOOSE PROFILE (FORCED) - ENTER PATIENT'S DATA - START COLLECTION start button - AUTOMATIC FINISH. Before starting the record, check or adjust and set these parameters - they cannot be changed during recor clean and absolutely dry the splrometric sensor and measuring mesh required profile clinical parameters (spiro parameters) ‘selection of the tast type (bronchodilator, bronchoconstrictor test) type of dosage cholee of inspiratory and expiratory forced spirometry (complete spirometry) / expiratory forced spirometry (expiratory) ‘The examination will be automatically finished after the time (set In profile) Is up, it can be also stopped at any time by the stop key. Ifthe actual measuring is accepted, confirm it by pressing the accept button. Press the print keys, The device wil start printing the results of the gained values during measuring on thermal paper. ‘The measurements are automatically stored in the record files! Evaluation of both tests: The basic examination ends whh the acceptance of three procedures. Then a table Is displayed next to three valid procedures (graphics) in the flowivolume graphic chart the table includes measured values FEV1, FVC and PEF compared with the precictive values for individual procedures. At the same time the programme highlights the best curve, You can manually choose a cifferent curve by clicking an appropriate procedure at the displayed table, At the same time there are reproducibility of FEV1, FVC and PEF parameters displayed (e.g. FVC+ means that FVC is reproducila, FVC- means that itis not reproducible) 4.5.4.4 Inspiratory and expiratory forced spirometry (complete) + Switch the device on by pressing the on /off button. + Check, whather the spirometer is correctly calibrated. + Choose the printing record profile menu — profile setup — forced and follow the instructions on the display of the device. The examination includes a fulfiment of at least three correct (accepted) measurements (procedures). + Make sure, that the selection of the complete spirometry is switched on - menu - profile setup - forced - adjust « spirometry mode - inspiratory and expiratory forced spirometry (complete). ‘+ Enter the patients name and date (date of birth, sex, weight, height and race); this will be used for the calculation of the predictive values and for the record analysis - press the patient button ‘+ Explain carefully to the patient the course of the test, eventually demonstrate the test clearly ‘+ Ask the patient about possible contra - indications, recent ilnesses, used medicaments and whether the patient is f@ smoker or & non-smoker. Measure the weight and height of the patient (without shoas) - height of the handicapped people can be also measured as length of their ams (arm span). ‘+ Make sure, that the patient takes off any tight clothes, as this could misrepresent the test results ‘+The patient should sit comfortably throughout the test with his ner head slightly bent forwards. Spirometric sensor hhas to be at horizontal position. ‘+ Ask the patient to put the nose clip on and check the tightness by requesting the patient to breathe through their page 23 of 51BTL-08 Spiro INSTRUCTION MANUAL + Pass the patient the spirometric module. The patient must grasp the spirometric module preferably with both hands and higher lips must hold the spirometer mouthpiece on the outside, + Ask the patient to breathe calmly an casually + Check the cleanness of spirometrc sensor and measuring wire-gauze + Start the measurements by pressing the start button ‘+ Ask the patient to breathe calmly and maximally into the pneumctachograph and straight after that to do a ‘maximally forced aspiration and maximally forced expiration - and at the same time encourage the patient by ‘saying "more and more” and “even deeper" in the stages of maximum aspiration and expiration + Let the procedure finish either automatically or by pressing the stop button, ‘+The report on the quality of the procedure on the cisplay of the device will help you to accept or refuse the accomplished procedure. Inform the patient, how to do the next procedure well or even better, and assure hirvher, that procedure was performed correctly. In the case of an unsuccessful measuring, perform the collection ‘again by pressing the start button, if the test was performed correctly, choose accept and continue with ‘measuring. WWe recommend accomplishing 3 consecutive measurements for a correct comparison ofthe results. + Give the patient enough time to relax (15 - 308) between the repeated procedures, otherwise the patient will not 'be able to perform another forced aspiration and expiration which can lead to hyperventilation of the patient, + Repeat it all uni there are atleast three procedures accepted or the tests fished prematurely by pressing the analyse button (displayed on the bottom line of the touch screen after pressing the accept button). The tetal number of procedures should not exceed eight + Check the reproducibility of FVC, FEV! and PEF parameters, + Carefully take the mouthpiece and the nose clip from the patient using a plece cloth to avold direct contact with your skin and the mouthpiece. 4.5.4.2 Expiratory forced spirometry (expiratory) ‘+ Switch the device on by pressing the on /off button. + Check, whether the spirometer is correctly calibrated, + Choose the printng record profile ~ menu ~ profile setup ~ forced and follow the instructions on the display of the device. Examination includes a fulflment of at least three correct (accepted) measurements (procedures) + Make sure, that tne selection of the complete spirometry is switched on - menu - profile setup - forced - adjust « spirometry mode - expiratory forced spirometry (expiratory) ‘+ Enter the patient's name and data (date of birth, sex, weight, height and race); this will be used for the calculation of the predictive values and for the record analysis - press the patient button + Explain carefully to the patient the course of the test, eventually demonstrate the test clearly ‘+ Ask the patient about possible contraincications, recent lnesses, medicaments used and whether the patient is a smoker of @ non-smoker. Measure the weight and height of the patient (without shoes) - height of the hancicapped people can be also measured as length of their arms (arm span). + Make sure, that the patient takes off any tight clothes, as this could misrepresent the test results ‘+The patient should sit comfortably throughout the test with hisiher head slightly bent forwards, Spiremetric sensor hhas to be at horizontal position. ‘+ Ask the patient to put the nose clip on and check the tightness by requesting the patient to breathe through thelr nose. page 24 of 51BTL-08 Spiro INSTRUCTION MANUAL ‘+ Pass the patient the spirometric module. The patient must grasp the spirometric module preferably with both ands. + Ask the patient to breathe calmly and casually ‘+ Chack the cleanness of spirometric sensor and measuring wire-gauze. ‘+ Start the measurements by pressing the start button. ‘+ Ask the patient to maximally forcefully Inspire (aside the spirometric module), immediately after that enclose the mouthpiece of the spirometer in histher lips and maximally narrowly breathe into the spirometric module. Encourage your patient during hisiher maximal expiration by saying "more and more” and "even deeper” + Let the procedure finish either automatically or by pressing the stop button, +The report on the quality of the procedure on the cisplay of the device will help you to accept or refuse the accomplished procedure. Inform the patient, how to do the next procedure well or even better, al the end assure hinvher, that the procedure was performed correctly + Give the patient enough time to relax (15 - 30s) between the repeated procedures, otherwise the patient will not bbe able to perform anather forced aspiration and expiration which can lead to hyperventiation of the patient. ‘+ Repeat it all, until there are at least three procedures accepted or the testis finished prematurely by pressing the analyse bution. The total number of procedures should not exceed eight. + Check the reproduciblity of FVC, FEV and PEF parameters, + Carefully take the mouthpiece and the nose clip from the patient using a plece cloth to avold direct contact with your skin and the mouthpiece. 4.5.2Examination in relaxed profile ‘An examination in the relaxed profie wil test the changing volume of lungs at the beginning of a relaxed expiration ~ ‘when the lungs are completely filed, to the end of expiration — when the lungs contain only a residual volume and opposite. Course of examination scheme. SWITCH ON device on/off - CHOOSE PROFILE (RELAXED) ~ ENTER PATIENT'S DATA ~ START COLLECTION ‘start button — AUTOMATIC FINISH Before starting the record, check or adjust and set these parameters — they cannot be changed during the record: + clean and absolutely dry the spirometric sensor and measuring mesh clinical parameters (spiro parameters) + required profile ‘The examination will be automatically finished aftar the time (set in profile) is up, it can be also stopped any time by the stop key. If the actual measuring is accepted, confirm it by pressing tne accapt button. Press print keys. The device will start printing the results of the gained values during measuring on thermal paper. ‘The measurements are automaticaly stored in record fles! ‘+ Switch the device on by pressing onvoff. + Check, whather the spirometer is correctly calibrated, ‘+ Explain carefully to the patient the course ofthe test, eventually demonstrate the test clearly ‘+ Choose the printing record profile ~ manu ~ profile setup ~ relaxed and follow the instructions on the display of the device. The examination includes the completion of at least three correct (accepted) admeasurements (procedures) ‘+ Enter the patient's name and date (date of birth, sex, weight, height and race); this will be used for the calculation of the predictive values and for the record analysis - press the patient button page 26 of 81BTL-08 Spiro INSTRUCTION MANUAL ‘+ Ask the patient about possible contra indications, recent iinesses, medicaments used and whether the patient is a smoker of @ non-smoker. Measure the weight and neight of the patient (without snoes) - height of the hhandicapged people can be also measured as length of thelr arms (arm span) |e, the maximum distance between the tops of their middle fingers. ‘+ Make sure, that the patient takes off any tight clotnes, as this could misrepresent tne test results ‘+The patient should sit comfortably throughout the test with hisner head slightly oent forwards. Spirometric sensor has to be at horizontal position + Ask the patient to put the nose clip on and check the tightness by requesting the patient to breathe through thelr + Pass the patient the spirometric module. The patient must grasp the spirometric module preferably with both hands and his/her lips must hold the spiremeter mouthpiece on the outside, + Ask the patient to breathe calmly and casually ‘+ Check the cleanness of spirometric sensor and measuring wire-gauze. ‘+ Start the measurements by pressing the start button + When the curve crosses the first vertical dashed line (atleast 6s atter pressing the START button), ask the patient to perform a quick, but not hard maximal aspiration foliowed by instantaneous maximal slow expiration (so - called EVC procedure) - encourage the patient during his/her maximal aspiration and expiration by saying "more and more” and "even deeper’ + Let the patient breathe calmly again, + Before the curve crosses the second dashed line, ask the patient, to perform maximal siow exelration followed by Instantangous fast, but not forced maximal aspiration (so - called IVC procedure) - once again encourage the patient during his/her maximal expiration and aspiration by saying "more and more" and "even deeper’ + Lethe patient know the end of the procedure and let hinw/her breathe calmly again, + The procedure will finish either automaticaly in 30 seconds after pressing the start button or by pressing the stop. button + Accept the correctly performed procedures. + Give the patient enough time to relax (16 - 30s) between the repeated procedures, othenwise the patient will not be able to perform anather forced aspiration and expiration wich can lead to hyperventiation of the patient. ‘+ Repeat it ll, untl there are at least three procedures accepted or the testis finished prematurely by pressing the analyse button (displayed in the bottom line of the touch screen after pressing the accept button). The total number of procedures should not exceed eight ‘+ Carefully take the mouthpiece and the nose clip from the patient using @ piece cloth to avoid diract contact with your skin and the moutnpiece. To finish the measurements, the stop button will appear during each procedure. In case of an unsuccessful measurement carry out the collection again by pressing the start bution, if the test was accomplished correctly, choose accept and continue with measurements. WARNING! Patients with COLD (Chronic Obstructive Lung Disease) can take a longer time to breathe out and may faint During and after the measurements, there are SVC, ERV, IRV and TV values dlsplayed on the sereen along with the volume [V]/ time [] curve. All procedures are shown on the display, including a graphic chart of slow vital capacity for the best performed aspiration / expiration of the current patient, compared with a selected predictive value, page 26 of 51BTL-08 Spiro INSTRUCTION MANUAL 4.5.3 Examination In mvv profile The examination in mvv profile will test the maximal alr volume breathed out during voluntary ventilation, This measuring uses the volume [V] time [] graphic chart Course of examination scheme SWITCH ON device on/off - CHOOSE PROFILE (MVV) ~ ENTER PATIENT'S DATA ~ START COLLECTION start button - AUTOMATIC FINISH. Before starting the record, check or adjust and set these parameters — they cannot be changed during the record! + clinical parameters (spiro parameters) + required profile + Switch the device on by pressing on/off. + Check, whether the spirometer is correctly calibrated, ‘+ Explain carefully to the patient the course of the test, eventually demonstrate the test clearly + Choose the printing record profile - menu ~ profile setup ~ mvv and follow the instructions on the display of the. device. The examination Includes the completion of at least three correct (accepted) acmeasurements (procedures) ‘+ Enter the patients name and date (date of birth, sex, weight, height and race); this will be used for the calculation of the predictive values and for the record analysis - press the patient bution ‘+ Ask the patient about possible contraindicatione, recent Inesses, medicaments used and whether the patient is a smoker of @ non-smoker. Measure the weight and neight of the patient (without snoes) - height of the hhandicapged people can be also measured as length of their arms (arm span) le. the maximum distance ‘betwen the tops of their middle fingers. ‘+ Chack the cleanness of spirometric sensor and measuring mesh. ‘+ Spirometric sensor has to be at horizontal position ‘+ Tell he patient firstly to breathe calmly, and then ask himyher to start breathing with maximal depth and frequency for a period of 15 seconcs. ‘+ Press tne start button to start the testing ‘+ The patient breathes calmly. When the displayed curve crosses the first dashed line (6s after the start of measuring), ask the patient to breathe with maximal depth and frequency and encourage the patient until the curve crosses the second vertical line (21s after the start of measuring). + After that, the patient can go back to slow breathing. Keep the ideal breath frequency of 90 - 110 breaths per ‘minute during the actual measuring, according to the condition of the patient. Wie recommend using the nose clip. ‘+The examination wil finish automatically after a lapse of time pre - set in the profile; t can be also cancelled any time by pressing the stop button. To confirm the actual measuring, press the accept button. ‘+ To finish measurements, the stop button will appear during each procedure, In case of an unsuccessful measurement carry cut the collection again by pressing the start button, ifthe test was accomplished correctly, choose accept and continue with measurements + A.view of the records from of the first procedure can be obtained by the analyse button (displayed on the bottom line of the touch screen - after pressing the accept button). this view will show you the current measured results and values of the spirometric curve. WARNING! This Is premature termination of examination, and it is impossible to continue in further measuring after that. ‘+The BTL-08 Spiro will save the results from three consecutive collections. Ifthere are three corract measurements, received (by the accept bution) ~ then the results from the measurements wil be displayed on the screen page 27 of 81BTL-08 Spiro INSTRUCTION MANUAL Volume [v]- time [t] curve and a table with the measured parameters compared with the predictive values for every accepted procedure are subsequently displayed on the screen during the measuring. After accepting the third procedure, the table in the column ‘Best’ wil be completed with the biggest values of the measured parameters. The measuring is considered to be sufficient. the variability between the recelved procedures does not exceed 20%. Press the print Keys. The device will start printing the results of the gained values during the measuring on thermal Paper. The measurements are automatically stored in the record fles! 4.6 BTPS CORRECTION ‘Air passing through the pneumotachograph during aspiration has a certain temperature, relative humisity and Pressure, corresponding to the conditions of the room, where the measuring is provided. These conditions are referred to as ATP (ambient temperature and pressure). Air in the lungs vil warm up to the body temperature and wil saturate with water vapour to almost 100% - so-called BTPS conditions (body temperature and pressure saturated vith water vapour) ‘This effect will change the air volume in the lungs. Therefore the spirometric values are re-counted for BTPS conditions, to compare the gained results under different ambient conditions. ‘The pneumotachograph BTL-08 Spiro includes all the needed sensors — they measure temperature of the ambient alr, relative humicty and barometric pressure ~ so the device is able to do the ATP correction for BTPS automatically. BTL-08 Spiro measures barometric pressure that is not recalculated to the sea level, so called "absolute / local barometric pressure". This is not the same ke the values of barometric pressure given by weather station, whieh are recalculated to the sea level 4.6.1ATP conversion into BTPS ‘The resultant values in spirometry are incicated in values converted to STPS. Veteg = Vare * (Trow! Tame) *{[ Para = Prou(Tano. Hane)! [Para = Proa(Tboays Hoo) 1) ‘Where: Vares ~ gas volume converted to BTPS conditions \Vare~ gas volume measured at ATP conditions Treay~ human body temperature in Kelvin (310 K) ‘Tino — ambient temperature in Kelvin Pans ~ atmospheric pressure at ATP conditions s2o(Tano, Hare) — vapour pressure at ATP coneltions ol Tinay, Hoo.) ~ vapour pressure at BTPS conditions is 6282 Pe, i €. 47 torr Hone ~ lative Rumicty Hey ~ relative humidity in the lungs (100 %) 4.6.2Measurement reliability and INTERPRETATION We consider the parameters to be correct, if they ware evaluated from the correctly performed procaduras on a propery calibrated device and under the conditions sultable for the patient. Therefore itis the operators responsibilty to check the physical environmental conditions and also the calibration validity. Then after the completion of each Procedure, the operator is asked to evaluate it — elther the procedure is accepted or there will be ancther one Performed! In the forced profle the operator wil automaticaly receive addtional information on the FVG procedure on the display - verbal classification (e.g. breathe out faster), and reproduciollty of some parameters (FVC, FEV1 and PEF), For these and other reasons the operator of this device should be properly and regulary trained, ‘The device in the forced profile provides an automatic interpretation of the results (Enright, BTS, ATS) on the basis of ‘entered data about the patient and a selected system of the predictive values. Its at the most advisable to double- check the accuracy of the entered specifications about the patient (age, sex, height etc.). However, itis up to the operator and avery doctor to take into consideration, how to use the resulls ofthis automatic interpretation, It is necessary to mention, that the device, and especially the measuring mesh of the pneumotachograph, must be properly taken care of. In particular keeping the cevice clean. Otherwise, some of al the parameters can be unreliable regardless of the results ofthe calibration, page 28 of 81BTL-08 Spiro INSTRUCTION MANUAL 3 Measurement results and their acceptance (FVC measurement) ‘The measurement results are acceptable, I + they are without = coughing closure of the vocal cords in the fist seconds of expiration early interruption of expiration diferent intensity (consecutive measurements should not dramatically vary) 5 escaping of air around the mouthpiace or through the nose 2 blocked mouthpiece (9, with tongue) + they have a good start ‘the volume removed by reverse extrapolation is lower than OSI forFVE S31! 5% FVC for FV > 31 time untll PEF Is lower than 120 ms + expiration > the graphic chart volume / time finishes with a horizontal curve, that lasts . a reasonable time” (volume — ‘ime curve changes more, than 0,025 | per 1 second and longer time, and the patient exhaled longer than 3 seconds = for children up to 9 years included and longer than 6 seconds = for a patient 10 years included or older) or © the patient cannot continue with expiration any more + the three accepted measurements must comply with these tests ‘the difference of the two biggest values FVC is lower than 0.15 | the difference of the two biggest values FEV" is lower than 0.151 if the previous two eriteria are not executed, follow these procedures: + collect ackitional measurements and examine, whether the above mentioned eriteria will are fuiflled + the total number of measurements Is already & + the patient cannet continue any more ‘+ the best curve willbe chosen automatically, according to the eriteria ofthe biggest total of FEV1 +FVC values and the subsequent parameters will be calculated trom this curve + print of the best values FVC and FEV1 can be also selected to the resultant table ~ so - called Best FVC and Best FEV Evaluation of the measurement acceptance according to A.R.R.D. [1]: ‘Qualitative aspect Griterion Faster star VEXT > 5% of FVC and > 160m More intensive expiration PEFT> 120 ms[i]or PEFT> 8 ms ‘Without coughing '50% flow drop in the first second Longer expiration FET100% <6 s Deeper expiration flow> 0.2 Vs up to 20 miFVO, More intensive expiration ‘@PEF> 10% Deeper aspiration ‘GFVC > 200ml and 5% best FUG. Faster exoiration ‘GFEVi > 200m and 5% best FEVI Good fest ‘with no errors FVC reproducibility at least 3 accepled procedures. Difference of the 2 biggest FVC up to 0.21 for ‘each of them FEVT reproducibinty at least 3 accepted procedures. Difarence of the 2 biggast FEV1 to the 0.21 {or each of them PEF reproduclblity 2 biggest PEF up to 10% TVW to shor test MV itime shorter than 128 page 28 of 51BTL-08 Spiro INSTRUCTION MANUAL Algorithms for a verbal evaluation of the record according to Enright and 87S algorthms, mentioned in the figure, see below: ENRIGHT INTERPRETATION Ccheck tne quay of tne procedure oY ssittgn <2 re mer uune, <> ren tieratne dn { sprctlQht ¥2eve spore 60% presi vats? rev aboveuuny MS, Bounsary spond 2 eve apove 80% presict values? FEV, above 60 “predict values? YS) SGM ev sbove do % prec. ates? 55M serious obstructing —___] "° spiromety BTS INTERPRETATION son check me quay otine proceaure restnonve yes ne + “Gsorder = FEV, 8 FVG «80% preci values? "rector common spirometry YES 4 4 ye ne common Tediees FEV) <—— FEV, <80% predict. values? FEV; < 80% predict values? me spirometry ‘common spirometty yes 4 yes ro veaucearve «7° — rev, Fev, <60% preset values? > S10 commen doves oan stony revcsovprocvauer > MM sarous selbken Note: FERSFEVIEVC page 30 of 51BTL-08 Spiro INSTRUCTION MANUAL 5 SETUP MODE 5.1 MAIN MENU Enter the main menu from the regime of monitoring the aspiratory curves. by pressing the menu button. You can ‘enter the menu also through the touch screen. To enter the main menu of the device, press the touth screen button ‘with the menu sign (bottom right on display). You can choose from these ostions: records file (data management) profile setup calibration device setup patient selection doctor selection 5.1.1Records file ‘This menu allows recalling, viewing and printing the last performed collections. The collections are saved In the memory of the device automatically. Incase the memory is ful, the next performed collection will overwrite the oldest record stored in the memory. The records marked as archive (the mark bution; ~ sign is displayed in front of the record), always stay in the memory of the device and are not over«ritten (that means thay must be deleted manually) ‘You can do the following operations with the chosen record: ‘+ printit repeatedly with a selected setup, as twas collected View the record on display rmark/re-mark the record as archive delete a selected record or al the records together display the records in optional order according to the attrioute - archive, date, name, or personal identification number Note: ‘The records are saved in the memory of the device in compressed form, in order to enter as many records in the Gevice as possible; therefore during the first archive entry the device must convert the records into a readable form, ‘This operation may even last several seconds depending on the number of saved records, 5.1.2Profile setup ‘The profiles are used for a quick setup of the device and its immadiate preparation for printing. They are preset parameters of tne collection and printing configurations, The parameters of the basic profiles are preset by the manufacturer. The profiles can be set in the device menu before each examination, but nat during measuring, ‘The device has 3 basic profiles: + forced profie (button forced) is used for examination of forced spirometry + relaxed profile (button relaxed) for relaxed spirometry and ‘+ mvv profle (button mvv) for maximal veluntary ventilation, ‘Apart from these three, even other profiles can be created (itis a cyclic selection by pressing the profile button) the ‘existing profes can be modified or eventually deleted (except the basic profiles, that cannot be deleted) page 31 of 81BTL-08 Spiro INSTRUCTION MANUAL 5.1.2.1 Forced, relaxed and mvv profile properties setup For each profile you can preset some of these parameters according to the type of profile: + name of the profile (can be changed only for user profiles) + type of the profle (can be changed only for user profiles) + predictive values (according to experimentally gained and evaluated measurements for a description see chapter Precictive values) + spirometry parameters according to type of the profie + automatic printing (selection on / off automatic printing after the end of measuring) + print setup © data printed in the record header (setting the printing header) > _ Interpretation in header (print /no print) spirometry graphic chars (print / no print) printer type (intemal / external - USB) + automatic stop (the testis / is not auomatically finished after a lapse of time, which is recommended by the document [3] ATS / ERS 2005, see chapter List of used literature) ‘+ Interpretation (choice of Enright, STS or ATS) + broncho-dilatation test © Name of broncho-cllatation material type of dosage (ug or mg/m) ° quantity + broncho-constriction test ame of broncho-constrctive material type of dosage (ug or mg/m) ° protocol + spirometry mode inspiratory and expiratory forced spirometry (complete) forced expiratory spirometry (expiratory) 5.1.3Calibration ‘When choosing the calioration, the folloving buttons are displayes: ‘syringe volume setup ~ setting the capacity of the calration syringe (3 litres — syringe supplied by BTL) + calibration records ~ record database of performed calibrations + callbration setup — setting the total number of manoeuvres performed for calloration and check calibration Calibration records ‘There Is possible to enter, select, edit and delete all records of appropriated spirometric sensors.To this purpose we recommend to mark spirometric sensors with a number. Entrance to this menu is possible from on-line mode as well by pressing of calllr key, eventually by pressing call button on the touch panel Further button calibrate enables to perform calibration of selected sensor. When specified spirometric sensor is selected It Is possible to perform the verifcation of performed calibration by pressing the button calibration check at the bottom status bar of display. Calibration Connect the calibration syringe firmly with the spirometric module. Press the start button to intiate the calibration. Carry out a total filing and emptying of the calibration syringe (the best Is the 3 Itre capacity) according to the total umber of set manoeuvres in three different speeds according to the instructions on the calloration cylinder on the display. ‘After completion of the last manoeuvre, stop the calibration by prassing stop button and a table with data for inalvidual calibration procedures and the resultant calibration coefficient for inspiratory and expiratory part will be cisplayed on the screen, Everything willbe saved in the database of the calibration records, The calibration result is possible to print as well Calibration check Connect the calibration syringe fmiy with the spirometric module. Press the start button to intiate the verification of the calibration. Carry out total fling and emptying of the calibration syringe according to the total number of set manoeuvres, alvays at a specified speed according to the calibration syringe bar-diagram on the display. ‘After completion of the last manoeuvre, finish the verification of the calibration by the stop button, and a table with ‘data for individual calibration procedures and resulting deviation will appear on the screen. Everything wll be saved in the database of calloration records. page 32 of 51BTL-08 Spiro INSTRUCTION MANUAL It this deviation is greater than 3,5%, then itis necessary to perform a new user calibration of the device. \Verfication of the calloration must bé carried out at least 1x a day. or more often if necessary. For correct function of unit, we advise the operating staff to perform the calibration and verification regularly the best Is every day and after every replacement of spirometric sensor and always after its cleaning, Warning Spiromatric sensor connected to the pneumotachograph without insertad silicon seal is nit possible to calibrate! Calibration setup ‘This submenu allows entering the total number of manoeuvres for performing of calibration or calibration verification. In both cases it is possible to select minimally three and maximally nine manoeuvres, \We do recommend performing nine manoeuvres for calbration and three manoeuvres for calibration check. 5.1.4Device setup In this submenu you can choose from the following items: + choose a profle, in which the device will star after svtching-up (profile selection after the start) + set the track intensity of the spiro signal during printing (line width) ‘preset the information displayed on the patient's medical record (patient's record setup) ‘setup optional specifications of the patient (patient's optional specifications) preset printing parameters and type of paper used (paper and printing setup) information on the module center the next user setup menu of the davice (user setup) 5.4.4.4 Starting profile - selection of profile after start ‘You can choose a profile, which will be preset on the device immediately after activating it by the on Joff button 5.4.4.2 Line width Here, you can set the track intensity for printing the spirometrie curve, The setup needs to be adjusted according to the paper used. The setting only influences printing the actual spiometric curve, and not printing other information (texts, pictures). Optimal printing can be achieved through this setup together with setting the suitable paper sensitivity (see above), 5.1.4.3 Medical record of the patient-patient’s record setup Activated items will appear when entering the patient's data and can be filed in. They are saved together with the Patient. You can activate these items on the patient's medical record, + name surname name 2 Identifcation number (personal identification number ) ate of bith sex ‘weight bicod pressure height cardiac pacemaker race smoker 2 user- defined items - thelr meaning and description can be set in Optional specifications of the patient. 5.1.4.4 Optional specifications of the patient In this part you can define names of two optional items in the patient's record ~ for example diagnosis, general condition. page 33 of 81BTL-08 Spiro INSTRUCTION MANUAL 5.1.4.5 Paper and print setup ‘You can find important parameters here relevant to printing. You can set the resolution of the USB printer. paper sensttvity and paper entry during the changeover. ‘The paper sensitivity setup is important for optimal printing and tegether with the track width setup entirely influences the quality of printing, More about paper insertion Is mentioned in chapter Printer and paper. 5.1.4.6 Module information ‘This part displays clearly all the crucial information about the configuration of the connected module. It Is a serial number of the module, module type, firmware version, ate. You will need this information in case of eventual communication with the business or service department. 5.4.4.7 User setup 5.1.4.7.1 Time and date ‘Setting the date and time in the device. Date and time are saved together with the records and are printed out on the made records. The preset date and time of the device are of course stored in the memory even when storage batteries are cischarged and the device is disconnected from power mains, 5.1.4.7.2 Display contrast You can set up the required contrast of the display. The function is the same as when pressing the contrast button on the touch screen. The contrast Is set by pressing the arrow on the touch screen, or on the Keyboard, Note Ragulation of the contrast on the colour display may change the colour presentation ofthe actual chromatic diagram. 5.1.4.7.3 Language options This isa setup of language, In which the device communicates with you. The modification will always display when the Gevice is switched on again 5.1.4.7.4 Touch screen calibration It the buttons on the display other than requested respond to buttons pressed on the touch screen, itis necessary 10 calibrate the touch panel. The calibration procedure is apparent from the screen of the device. Its advisable to use a ‘ouch pan pointer during tne calioration and follow the instructions, markad on the screen of the device. It the calibration is unsuccessful, it can always be interrupted by pressing the esc button, ‘The result ofthe touch screen calloration can be verified in the function “touch screen function test”. Direct initiation of the touch screen calloration from the keyboard can be done by entering the menu by pressing the start key, 5.1.4.7.5 Files correction Due to disturbance, or the device deficiencies, the saved data will get damaged and the device can indicate errors in the fle system (loss of some records, loss of some saved patients). This function inttalizes diagnosis of the fle system and tries to rectify the errors preferably without loss of the saved cata. Depending on the number of saved ‘cata, the function can take @ considerably long time (hours), therefore we recommend to run this function overnight ‘etc. Once You start the function, you must wait for its completion, or reset the device, see chapter Function summary of keyboard buttons, 5.1.4.7.6 Files system format ‘The function initializes the whole file system, Le, itwill delete all the saved data in the device and will put the device to the initialized postion (starting position as when purchased). This function is used only during a major accident, or if the user wants to inialize the device completely 5.1.4.7.7 Default setting without data loss The function will set the device into a state as when purchased (it wil set the language, colours ete.) and at the same time will keep the saved data ofthe profiles, patients, doctors and records, 5.1.4.7.8 Device sleep mode interval ‘This will set up a length of downtime after which the device Is switched off page 34 of 51BTL-08 Spiro INSTRUCTION MANUAL 5.1.4.7.9 Battery level indicator You can suitch on / off the audio alarm (short fast whistling) of the discharged battery. Visual indication cannot be switched off 5.1.4.7.10 More... Press thls button and you can continue wth other user setup (more items}: + device information - all crucial information on the device configuration Is clearly displayed here. Such as the serial number, firmware version, time when the device is restricted In ts function, the temperature of single parts of the device, firmware version of the printing module and hardware key configuration, This information is needed whan communicating with the business department. + hardware key setup - configuration of the device can be remote-controlled. For the actual hardware configuration see menu device information + access password setup — to prevent the device from any unauthorized manipulation. you can activate the demand on entering the password when switching the device on. It's possible to turn the demand on password (on/off, or change the password. The password can be any long numeric combination. If you forget the password, always enter password 00000000. + key sound - on /off function of key sound, + cancel the patient after the collection — yes | no option to cancel the entered patient immediately atter the collection + save the actual doctor - yes /no option to store the name of the actual doctor. + other ~ more itams of the user setup name of the hospital — function of inserting the name of the hospital, which will be printed out with the record. Initial mode - mode, that wil be selected immediately after the device start-up by the on Joff button colour schemes ~ setting the coloured versions of the display. There is @ number of colour schemes preset by the manufacturer, that you can edit or delete or create your own colour schemes. Every displayed item can have its own colour, colour of the curves - choice of colour tront and background of the graphic chart. active and inactive curves. A number of colour schemes preset by the manufacturer, that you can edit or delete: or create your own colour schemes. Every displayed itam can have its ovin colour. © default race of the patient ~ function of default setup of the patient's race 5.1.5 Patient selection The device contains a database of patients. Its possible to enter, edt and delete the patients, A new patient can be also entered in on - line mode by pressing the patient button. The entered values for the patient can be adjusted in the device setup, see chapter Medical record of the patient - patient record setting, The qumber of patients is limited only by the capacity of the memory The patient's specifications are printed out in the header of the record according to the setup of the relevant profile. Saved patients stay in the memory evan when the device is switched off. Function of tne actual pre-set patient is always set empty when the device is switched on, 5.1.6Doctor selection ‘The device includes @ database of doctors, which is used for setting, editing or deleting of entered doctors. The ‘umber of doctors Is limited only by the capacity of the device memory. Data about the doctor is printed out in the footer ofthe record according to the setup of the relevant profi. Saved doctors stay in the memory even when the device is switched off, The function of actual pre-set doctor is always empty when the device is switched on, page 36 of 81BTL-08 Spiro INSTRUCTION MANUAL 6 ACCESSORIES ‘The device Is not intended for use in connection with other equipment, with other medical appliances and instruments ‘except those mentioned in ths instruction manual This lst includes specifications of all equipment that can be supplied with the device Mere detailed information on particular equipment can be found in tne enclosed leafiat. Standard BTL accessories: + 4x spirometric sensor, plastic mouthpiece and silicone seal (set) coase.o1sv100 © 1x nose clip for BTL-08 Spiro 008.146 25x motivation pietures for children - elephant coasp.o16vi00 + 25x motivation pletures for children - clown (c08SP.017v100, © 1k CD with service instructions Other standard BTL accessories for Spiro Pro plus + 1k ECG paper 112mm, roll 25m ‘c00e.108v101 +1 pen pointer for touch screen. .6000.099v101 + 1Kpower core ‘600.081 + 1x table holder for BTL-08 Spiro coase.o20v100 + 1x dust cover for the device + 1x spare fuse More standard BTL accessories for Spiro and Spiro Pro modules + tkaitach case Spiro ‘cossp.oztv100 Optional BTL accessories: + 1x spirometric sensor, plastic mouthpiece and silicon seal (set) coase.o18v100 + 4x calibration syringe for BTL-08 Spiro - capacity 3 tres ‘Coase o1avi00 * tx disposable paper mouthpiece” ‘c08se.012 + 4x antibacterial fiter for BTL-08 Spiro (0088°.013 + 1x cart for BTL- 08 Spiro Pro Plus 5002. 125100 + 1x cart for BTL- 08 ECG Mx, Sx & Spiro 5002.123v100 + tx cart for BTL- 08 ECG Lx & Spiro 5002. 128v100 “disposable paper mouthpiece can be also bought In specialized shops, Significant parameters for compatibility ‘with BTL spirometer are: mouthpiece length 71mm, inner @ 30mm, outer o 33mm * itis possible to buy standard accessories with Iisted supply number. page 36 of 51BTL-08 Spiro INSTRUCTION MANUAL 7 MAINTENACE AND DEVICE SAFETY Maintenance inspection with measurements of all the parameters of the device and recalibration Is necessary at intervals shorter than 30 calender months. Inspections and recalibration are accomplished by authorised service of BTL the device on the basis of the user's order. If the inspection is not performed to a defined deadline, the manufacturer is not responsible forthe technical parameters and safe operation of the procuct Keep the device clean, do not store and use it long - term in extremely dusty environments and do not submerge it into any liquid, Check every time before using, that the device and its accessories (especially cables) are not mechanically or othenwise damaged. Do not use ifthe device is damaged! Fuse replacement ‘The fuse is placed on the rear panel in a black round case (18). At first, make sute before the replacing, that the ower switch (14) is in position “0”, and then disconnect the power cord from the device. Turn the fuse case section lefwards by using a suitable screwdriver or a coin and remove the fuse. Insert the new fuse and fish the replacement in the similar way, but to the right. It is prohibited to insert a fuse with different specifications, than mentioned on the fuse case. ‘This operation may only be done by a person acquainted with this procedurs 1s 1 We recommend to Keep the packaging of the device. It Is useful to wrap the device during transport in this wrapping, hich provides maximum protection. Disconnect the power cord from the device and the accessory cables, Avoid major impact. Store transport the device only under the concitions defined in chapter Technical specifications. 7.1 CLEANING THE DEVICE SURFACE AND ITS PARTS Clean the device and its parts with a ligntly damped soft cloth only. To wash the device, use water or @ 2 %e detergent solution. Never use liquids containing alcohol, ammonia, petrol, thinners etc ‘To clean the device never use abrasive materials, as It could damage the surface of the device. None of the device parts are sterile and there is no need to stelize them. 7.4.1Cleaning the touch screen The surface of the touch screen can be cleaned by cleaning agents suttable for monitors, or agents used! for glass. surfaces. These detergents can be applied only by spray gun. LIGHTLY spray the cleaning agent on the centre of the touch sereen, wipe and polish the whole surface wlth a dry cloth. Press the cloth VERY GENTLY; otherwise the touch seraen could break ATTENTION ‘The cleaning detergent must not get under the edges of the touch screen; otherwise It could damage the device. ‘The cleaning detergent should not get into contact with any other parts of the device except the touch screen, 7.1.2Cleaning the paper sensors Every 6 montns wipe off dit and dust from the paper sensors with a soft brush or dry cotton ball. Sensors are placed Under the printer cover near the upper edge of the device (two black squares) and are reachable when the printer cover Is removed from the device. page 37 of 51BTL-08 Spiro INSTRUCTION MANUAL AND DISINFECTION OF SPIROMETRIC NTACT WITH THE PATIENT 7.2.1Hygiene During the splrometric examination and especially afer its completion, it Is necessary to follow basic sanitary regulations suppressing a risk of possibie infection \With respect to the possiblity of microbes getting into the internal part of pneumotachograph through the slicon seal \we do recommend separating the pneumotachograph from spiremetric sensor after each patient Place the uncovered phemotachograph preferably in the directions opposite to incoming patients - using the ergonomic spiromettic holder or designed stacker plate of spirometric trolley. ‘The pneumetachegraph BTL-08 Spiro is designed for users to select a degree of protection according to thelr needs. ‘The spirometer can be used in these configurations: + Disposable antibacterial filter — this is the safest use of the spirometer, all possible bacteria ‘and viruses get caught in the antibacterial fiter that is used by one patient and then diaposed, according to regulations valid for biological waste, Measuring equipment of the spirometer remains clean all the time. This technique also guarantees the most exact measurement, because the measuring sensor will not get contaminated Se + Disposable paper mouthpiece ~ using the paper mouthpiece lowers the risk of infection transmission by drect contact. The paper mouthpiece must be used by only one patient end propery cisposed of 25 biological waste, The measuring equipment of the spirometer must be cleaned. because it has been contaminated sth the patient's breath ~ the best is to use disinfection or sterilzation. We advise to disinfect | Steriize these pars immediately afer using the pneumetachograph: sprometrc sensor (24) and sileone seal (27) ~ see chapter Pneumotachograph description + Washable plastic mouthpiece — the below mentioned parts must be disinfected or sterlized after each patient, and this vay of using the spirometer can be also regarded as safe. After using, we advise to disinfect /sterlize these parts of the spirometer, after each patient: plastic mouthpiece (23), splrometric sensor (24) and silicone seal (27) ~ see chapter Pneumotachograph description. It in any doubt about the possibilty of the disposable antibacterial fer. infection / transmission of TBC, HIV or jaundice, we acivise the implicit use of Potential infection transmissions are: Direct contact: possible chance of contamination with upper ainvays diseases, intestinal infections and blood ‘transmitted infections (including jaundice and HIV), Infection transmission is possible through disposable microbial filter, pneumotechograph mouthpiece or through the ‘measuring mechanism (if the microbial fiter is nat used). The mentioned parts cannet only be contaminated with ‘saliva, but also with blood from open ulcers and scratches in the mouth and bleeding gums. Indirect contact: the potential possibilty of contamination with tuberculosis, viral Infections ete., transmitted by Groplets The most contaminated device parts: disposable antibacterial filter, mouthpiece and measuring mechanism (if the ‘microbial fter is not used, page 38 of 51BTL-08 Spiro INSTRUCTION MANUAL Prevention: © personnel: it Is recommended to use protective gloves when handling the spirometer or washing and cleaning the contaminated paris, also nands should be washed, immediately after work witn the spirometer + patients — protection from cross contamination: >” using disposable antibacterial filter ‘equipment parts that get in direct contact with the patient (antibacterial filter, mouthpiece, nose clip }, itis advisable to dispose of them aftr using, or in the worse case sterilize / disinfect sterilization or disinfection of all reusable parts that come into contact with exhaled and inhaled air (measuring mechanism) ~ we recommend to carry out sterilization or disinfection after every patient threat of risk of transmission of tuberculosis, or similarly aggressive diseases (2.9. HIV. jaundice ‘we recommend using the disposable antibacterial fters during the measurement © Itis advisable to use a flow of air after sterilization / disinfection to remove droplets of water from the measuring mechanism of the spirometer 2 it ls necessary to remember to accomplish calibration , after every sensor replacement, its ‘istribution, sterilizing and re-assembiing, in surgeries, where working mainly with patients with lowered immunity, we recommend a strict, use of the disposable antibacterial filter ‘When used by HIV positive people, we recommend sterilizing the device wlth a 2% glutaraldehyde dllution 2}. 7.2.2Cleaning We recommend cleaning the device after every patient with cleaning agents approved by competent authorties of that particular country. You can use for example Sekusept, Bacilol etc. And for the cables of the accessories you can use: 24 Incidur spray ate 7.2.3Disinfection CAUTION! The patient's parts and spiromatric sensor can be contaminated with bacteria and viruses of the Patient. Therefore it is necessary to use cleaning agents and procedures intended and authorized tor disinfecting. Pay attention to uncompromising use of only disinfacted mouthpieces, spirometric sensors and seals, Applications suitable for disinfection are for example Chiroseptol, Gigasept Instru AF or Sekusept forte in lution form. Disinfecting solutions: 1. Chiroseptcl 2% with exposure time 30 min, 2. Gigasept instru AF 2% with exposure time 30 min 3. Gigasept instru AF 3% with exposure time 15 min. 4. Sekusept forte 3% with exposure time 30 min, Working proces: 1. Removal of a part Intended for cleaning and disinfection 2. Cleaning the part - under running water 3. Disinfection of the part — entre submarsion of the part into a disinfectant solution with specified exposure ‘time. 4. Proper (multiple) rinse ~ under cold running drinking water 8. Airdry before utlization ‘The lifetime of the replaceable mouthpiece, splrometric sensor, seal and the nose clip is 1000 disinfection cycles Notice: We recommend using uncompromisingly the disposable antibacterial fiter in patients with TBC or HIV, but also with suspicion of these diseases. Warning: IH you use disinfectants containing aldehydes, then the alsinected parts of the spirometry can change colour (become. brown), page 38 of 51BTL-08 Spiro INSTRUCTION MANUAL We do not recommend using disinfectants containing peracetic acid or substances generating peracetic acid in lsinfecting solution. However, if you Use these disinfectants, the mechanical disengagement of the spirometric sensor can orcur and damage the sensor. 7.2.48terilization We advise to carry out sterlization according to standard recommendations for plastic object maximal temperature of 121°C and sterlization time 20 minutes. ‘without hollow parts at ‘After sterilization of the spirometric sensor itis necessary to let the sensor cool down for a temperature lower than 40°C before its next using, Otherwise the device will become mechanically damaged! ‘The lifetime of the replaceable mouthpiece, spirometric sensor, seal and nose clip Is 1000 sterilization cycles, 7.3 DEVICE SAFETY CAUTION! IN ‘The device is equipped with a protective system against the connection of different equipment other than supplied by the manufacturer; consequently It does not allow operation with equipment form other manufacturers. ‘The BTL- 08 Spiro has applied parts of BF type, ‘The device disuses any pharmaceuticals or matters, which would be applied or were an integral part ofthe device. Af ‘This connector relates only to the combined device BTL-08 ECG + Spiro. You will find its purpose in the relevant manual for BTL-08 ECG MT Plus and Lx. A 1, ‘This marked clamp is connected to the framework of the device. It relates only to the combined device BTL-OB ECG + Spiro, You willing its purpose in the ralavant manual for BTL-O8 EKG MT Plus and Lx. Safety precautions + Read carefully the service Instructions before first activation of the device. + All personnel, using the device, must have @ required service qualification in the health service; they must especially know the contraindications of the examination with the device, all potential danger and effective procedures to prevent infection transmission + All personnel, using this device must be knowledgeable in the servicing technique, maintenance and verifcation of the device and about the principles of safe work with the device, + Electrical mains connected to the device must be performed according to the existing valid standards (CSN 33 2140, IEC 364) and must be certificated according to these standards. if you are not sure, that the power mains. ‘supply is in perfect order, carry out a technical revision by an engineering inspector. + Crosseheck, whether the parameters of the power mains supply correspond with the requirements of the device: according to chapter Technical specifications and if the mains voltage switch placed on the rear panel apparatus |s svitched to the correct voltage according to the parameters of the power mains. + The device is designed to work in an environment defined in chapter Technical specifications. It must not be used ln an environment with threats of e.g. explosion hazard, or water penetration. The device must not be used in Connection with fammable anaesthetics, or oxidative gases (02, N20 etc) + Place the device out of direct sunlight and out of reach of strong electromagnetic fields, to avoid undesirable Interactions. In case of undesirable interactions place the device away from source of disturbance, or contact the authorised STL service centre + Before every use, examine the device properiy (loose cables, damaged cable insulation, functions of the display, Indicators, operating elements etc.) and in case of any discrepancy stop using the device and contact the authorised BTL service centre. if the behaviour of the device shows any divergences from the function procedure: described in the instruction manual, stop using the device and contact the authorised BTL service centr. page 40 of 51BTL-08 Spiro IN STRUCTION MANUAL + Ifthe device shows any signs of defects, or you are in doubt about its correct operation, stop working with the: device immediately. If you cannot detect the source of doubts even after careful reading through the instruction ‘manual, appeal to the authorised service department of the BTL device wthout delay. If the device is used contrary to this Instruction manual, or itis used in despite of the device showing functional clvergences from this instruction manual, then the user is responsible for any damage caused by the davicel + Do not disassemble the device in any case. Dismantling and unlocking the safety cover can cause denger of electric shock. Eventual replacement ofthe lithium battery and lead-acid storage battery must by carried out by authorised STL service centre + All materials and parts that come into direct contact with the patient's body (detergents used for cleaning the electrodes, mouthpieces...), must meet the appropriate standards, relevant to Irfation, allergization, toxicity genotoxicity, carcinogerity according to the standards ISO 10883 - 1, ISO 10993 - 3, ISO 10893 5. The user himself is responsible for al these materials and parts that were not supplied by the BTL device distributor, + Do not connect the connectors used for the accessories and the other connectors with anything other than the: equipment intended by the service instructions, as it can cause canger of electric shock and serious damage of the devic + The device does not radiate or does not use any toxic materials during its operation, storage and transport under the glven conditions. + When transferring the device trom a cold environment into warm, wait Before plugging into power mains, until the temperature levels (1 hour minimum). + When switching the device off and on, there is a time delay necessary of atleast 3 seconds. + The device does not cause any risk to the patients with cardiac pacemakers. + When disposing of the device after years of operation, itis necessary to remove the lithium battery and the lead- acid storage battery. Dispose of them in a proper way - do nct put the batteries into the communal waste. Then the device can be disposed of in the usual way. The device does not contain any toxic materials that could damage the environment when disposed of in the common way. Warning: removal of the batteries causes non reversible damage of the device, Execute only during ecological disposal of the device! Procedure: - Unscrew the lower cover of the dvi - Use suitable tools to remove the batteries (position of the batteries see illustration) ETL08 Spiro Itis not allowed to use the device and accessories other than according to the instruction manual, Use recommended protective equipment wnen working with the device. This device must be kept out of reach of the children. Do not remove any covers from the device. Repairs must always be provided by the authorised STL service contre. 7.4 CONDITIONS OF GUARANTEE ‘The manufacturer provides @ 24 months guarantee for the device trom the date of purchase. The lead-acid storage battery, expendable supplies anc mobile parts of the device (pneumotachograph) guarantee is proved for 6 months (guarantee does not apply to common wear of the parts). Contitions of the guarantee determine, if the device is not used in compliance with this instruction manual, or Lnprofessional intervention to the device Is carried out by third parties. In case of malfunction of the device always contact the STL service centre. page 41 of 51BTL-08 Spiro INSTRUCTION MANUAL TECHNICAL SPECIFICATIONS Type: BTL-08 Spiro BTL-08 Spiro Pro Display ‘ouch screen dmensions (rm) 20x89 ‘sereen resolution 320 x 240 RGB (colour) Keyboard: ‘Combined — funcional + touch screen buttons Discharged battery indication: acoustic + ight Printer: paper with (mm 112 /Aa through USB paper ype roll At — office paper printer resolution 7200 dpi in Y-axis, 500 dpi in X-axis 300 dpi ante ine, external trough USE Measurement parameters: TPS correction ‘auiomatc inspire expire yes yes forced profile FVo, Best FVG, FEVOTS, FEV, Best FEVI. FEV3, FEV8, PEF, FEVO 75IFVC FEVIFVC, FEVAFVC, FEVOFVC, FVO, Best FVO, FEV, Best FEV, | FEVO 7SISVC, FEVI/SVC, FEVISVC, FEVO, PEF, FEVIFVC, FEVOIFVC, | _FEVO'SVG, PIF, FIVG, FIVI, MEF7S, FIVG, FIV, PIF, MEF?5, MEFSa, | MEFS0, MEF25, FEF7S, FEFEO, FEF2®, MEF25, Lung age MMEF,FET25, FETSO'MiF7S, MESO WMiF25, PET. FFSO, FEFSQIFIF50, FEFSQ/SVC, FEVO7SIFEVE, FEV FEVS, FIVVIFIVC, VEXT, Lung age relaxed profile V0, ERV, IRV, TV, 1, NC wy protle MW MVE MR PREIPOST bronchoprovocatve test yes Predictive values ECCSIERS 1003, ECCS 1083, NHANES Il, Knudson 1983, Knudson 1976, Roca 1086, CRAPO 1081, ITS, Pertaca ~ Brazil, LAM, Gore ~ Austvalian, Zepletal 1977 ‘Slored records = 250 User defined profiles ‘nie Interpretation Enright, ATS, BTS ‘hig incentive ves Device weight (max. in kg: 32 Dimensions (in mm 330% 270% 74 ‘Operating conditions: ‘ambient temperature = 10°C10 40°C recommended ambient temperature + 17°C to =28°C (to avoid any provocative bronchial reaction) relative humidity 2556 10 85% barometric pressure 70 APa to 1100 APA: position herizontal page 42 of 81BTL-08 Spiro INSTRUCTION MANUAL operation ype. permanent Transport and storage conditions: temperature TDCi BO ‘elatve humility ete Bs barometric pressure 250 hPa to 1100 NP positon any storage ie year ‘ther conditions ‘Wansportaton only n supplied wrapping, recharge Storage battanies minimally ones a year ‘Technical specifications: flow range (ires/s) “16 bith inspire / expire) ‘accuracy (50 mvs 0 16 Is) 5.% oF 50 mils (Qreater valve apples) volume range (tres) 0,026 to Blires| accuracy (0,025 10.8) 23% or 50 mil (greater value apples) flow resistence 79 P88: IPS corrections: emperature sensor HIG Ae accuracy 23% for 25°C barometric press 70 APato 1200 AP accuracy = 2% mn mentioned range relative humidity sensor (Oto 100% RH accuracy £49 f0r 25°C, 3010 80% RH Device power supply: oWor Apu "OVA mains voltage TROT a vald aleve) A ~ 198 V to 252'V (230 V rated vattage), AC frequency SDHz 10 60 He Classification: protection cass Toth tunctonal grounding (accoraing 10 JEG 836, GSN 33 0600 and IEC 60601 - 1), voveinaltuse "THAT 250V, tube safety fuse S20 rn, according o|EG 127-2 ower sch ‘onthe back of he devies_ postion O and IP code P20 safely standards TECGO1 1 ECOOT 1-2, IECEOT 14 180 14071 spiromety standards EN 12896, ATS ERS standards 2006 ‘applied part type BF according to IEG 601-1 Internal chemical supplies: batlery Thiam Battory OR2O82 Teadhacid storage battery T12V/ 12 An, 48K97X82 mm, maintenance - fee storage battery capacity 3a hous charging time 10 hours lifcompletely discharged) PC connection: use page 43 of 81BTL-08 Spiro INSTRUCTION MANUAL 8.1 LEGEND OF THE MEASUREMENT PARAMETERS 8.1.1Forced spirometry FVC = Forced Vital Capacity [|] - maximal air volume the patient expires after maximal aspiration, hovever contrary to the vital capacity, te patient breathes cut as fast as possible PEF = Peak Expiratory Flow [ls], maximum speed of peak flow achieved during forced exolration. It depends on the ‘effort made with the cooperation of the patient, FEVo.7! ‘expiration, Time Forced Expiratory Volume [I] forced expiration of volume in defined time 0.765 from the start of the FEV1 = Time Forced Expiratory Volume [I], volume exhaled during the frst sacond of forced expiration of vital capacity -,one-second vital capacity" FEVS = Time Forced Expiratory Volume {], volume exhaled during the first three seconds of forced expiration of vital capacity, FEV6 = Time Forced Expiratory Volume [!], volume exhaled in six seconds of forced expiration of vital capacity, FEVO.7SIFVC = ratio [%] of forced expiratory volume 0.75 s from the start of expiration to maximum air volume: ‘exhaled as fast as possible by the patient after maximal aspiration, FEVI/EVC = ratio [2%] of forced expiratory volume 1 second from the start of explration to maximum alr volume: ‘exhaled as fast as possible by the patient after maximal aspiration FEVS/FVC = ratio [%] of forced expiratory volume 3 seconds from the start of expiration to maximum alr volume: ‘exhaled as fast as possible by the patient after maximal aspiration, FEVGIFVC = ratio [94] of forced expiratory volume & seconds from the start of expiration to maximum air volume ‘exhaled as fast as possible by the patient after maximal aspiration, PIF = Peak Inspiratory Flow [Vs] the biggest explratory flow value gained during the whole measurement, FIVC = Forced Inspiratory Vital Capacity [J], after the total expiration, forced aspiration follows to the maximum position, Fiv Forced Inspiratory Volume [I] forced inspiratory volume in the frst second, MEF75 = Maximum Expiratory Flow [ls] - specified when the measurement finishes, Its @ flow value during forced ‘expiration defined from the curve, when 75 % of the air volume remains in the lungs, MEF5O = maximum Expiratory Flow [Us], specified when the measurement finishes, IIs a flow value during forced ‘expiration defined from the curve, when 50 % of the alr volume remains in the lungs, MEF25 = maximum Expiratory Flow [Us], specified when the measurement finishes, iis a flow value during forced ‘expiration defined from the curve, when 25 % of the air volume remains in the lungs, FEF7S = Forced Expiratory Flow [Us] - specified after the end of measuring, ts 2 flow value during forced expiration defined from the curve, when 75 % of the alr volume was exhaled from the lungs. FEFSO = Forced Explratory Flow [Us] - specified after the end of measuring, it's a flow value during forced expiration defined from the curve, when 50 % of the air volume was exhaled from the lungs. FEF25 = Forced Expiratory Flow [Us] - specified after the end of measuring, its a flow value during forced expiration defined from the curve, when 25 % of the alr volume was exhaled from the lungs. MMEF = Maximal Mid- Expiratory Flow [V/s]. specified by calculation after the end of measuring, sometimes also referred to as FEF25 - 75% as maximal mid expiratory flow in mid half of the exhaled FVC. page 44 of 51BTL-08 Spiro INSTRUCTION MANUAL FET25 = Forced Expiratory Time [s], ime necessary for expiration of 25% from the FVC value, measured from the. start of measuring (Time Zero). its specified by a reverse extrapolation, FETS0 = Forced Expiratory Time [s], ima necessary for expiration of 50% from the FVC value, measured from the start of measuring (Time Zero), itis specified by a reverse extrapolation, MIF75 = Maximum Inspiratory Flow [Vs], specified after the end of measuring, It presents flow values during forced ‘aspiration, defines from the curve when 75% of the air volume is left to breathe MIFSO = Maximum Inspiratory Flow (V's), specified after the enc of measuring, It presents flow values during forced aspiration, defined from the curve when 0% of the alr volume is left to breathe in, MIF25 = Maximum Inspiratory Flow ls]. specified after the end of measuring, It presents flow values during forced aspiration, defined from the curve when 25% of the air volume is left to breathe PEFT = Peak Expiratory Flow Time [ms], time to PEF trom 10 % to 90 % of the FIF50 = Mean Forced Inspiratory Flow [ls], specified after the end of measuring, itis @ flow value during forced aspiration, defined from the curve when 80 % of the ar volume was breathed in to the lungs, FEFSOIFIFSO = ratio [%] ofa flow velue during forced expiration defined from the curve when 50 % of the air volume ‘was exhaled from the lungs, to a flow value during forced aspiration defined from the curve, when 50 % of the alr Volume was breathed into the lungs, FEVO.75/FEVE = ratio [%] of a forced expiration volume in the time of 0.75s from the start of expiration, to the volume: ‘exhaled within six seconds ofthe forced expiration of vital capacity, FEVI/FEVG = ratio [%] of a forced exoiration volume in the time of 1s from the start of expiration, to the volume exhaled within six seconds of the forced expiration of vital capacity FIVIIFIVG = ratio [%] of forced aspiration volume in the first second, to the volume of forced aspiration of vital capacity, when forced aspiration to the maximal position follows the total expiration, EVE = Extrapolated Volume [I] is used as a criterion for an expiration start. It prasants the exhaled volume In time: ‘rom the start of expiration unti the new time of expiration specified by reverse interpolation Lung age = [years], this parameter Is intended mainly for the patients as a motivational figure to stop smoking Flow [V/s] PEF = Poak Expat Flow FEVI= Tine Forced Expraton Volume Ve = Fored vil Capscty page 45 of 51BTL-08 Spiro INSTRUCTION MANUAL 8.1.2Relaxed spirometry SVC = Slow Vital Capacity [l], starts with deep expiration and finishes with maximum aspiration ~ but not forceful ‘Sometimes also referred to as EVC ERV = Expiratory Reserve Volume [I] - tis the difference in value of the maximum expiration volume and average value of the common breathing volume, IRV = Inspiratory Reserve Volume [1] - its the difference in value of the maximum aspiration volume and average value of the common breathing volume, ‘TV = Tidal Volume [I] -s the alr volume inspired or exhaled during one aspiration or expiration, also referred to as Vi IC = Inspiratory Capacity [it presents the biggest possible alr volume, tnat can be inspired after a previous relaxed expiration, IVC = Inspiratory Vital Capacity [] is the maximal air volume, that can be slowly inspired after maximal expiration. TV = tt vote IRV = iepator reserve volume IC inspiratory eapacty EC = exprstoy capacty ERV- exspatery reserve vlan IVC = ireiatory via copacty SVC cow vial apacty (xoiatow) 8.1.3Measuring of the maximum pulmonary ventilation volume MVV = Maximal Voluntary Ventilation {l]-the total air volume, that flows at a maximal forced ventilation during 1 minute, measuring must last for at least 12 seconds, then the values will be completed in 1 minute, MVVE = Maximal Voluntary Ventilation frequency [Hz], the average respiratory frequency measured during MV measuring MRE = Maximum Respiratory frequency [s], maximum measured frequency of respiration curing MVV measuring, page 46 of 51