1. IF THE TESTS PERFORMED ARE NOT BE ACCURATE AND PRECISE THE USER MUST OPERATE THE CALIBRATION PROCESS

2. THE DEVICE 1CALIBRATION REQUIREMENTS A 30MM DIAMETER MOUTHPIECE A SYRINGE -NOT LESS THAN 3LT -CERTIFIED FROM THE MANUFACTURER THE TEMPERATURE/BTPS CONVERSION TABLE

3. 2POWER ON THE DEVICE

4. 3BTPS VALUE TAKE NOTE OF THE BTPS VALUE

5. 4CREATION OF A DUMMY PATIENT PART. 1 AFTER A FEW SECONDS THE DEVICE SHOWS THE FOLLOWING SCREEN SELECT THE “ID” OPTION WITH THE CORRESPONDENT KEY

6. 4CREATION OF A DUMMY PATIENT PART. 2 SELECT THE “NEW PATIENT ICON” OPTION WITH THE CORRESPONDENT KEY

7. 4CREATION OF A DUMMY PATIENT PART. 3 INSERT DUMMY DATA AS A NORMAL PATIENT DATA INSERTION EXPLAINED ON THE USER MANUAL EVEN THOUGH ANTHROPOMETRICAL DATA ARE NOT RELEVANT DURING A CALIBRATION TEST. WE SUGGEST YOU INSERT YOUR OWN DATA

8. THIS PERMITS YOU TO OPTIMISE THE CONNECTION BETWEEN THE SYRINGE AND THE OPTOELECTRONIC TURBINE IN ORDER TO AVOID AIR LEAKS 5INSERT A PLASTIC MOUTHPIECE TO THE 3LT SYRINGE

9. 6CONNECTING THE DEVICE TURBINE HOLDER TO THE SYRINGE PART. 1

10. 6CONNECTING THE DEVICE TURBINE HOLDER TO THE SYRINGE PART. 2

11. 7OPENING THE SYRINGE PISTON THE PISTON MUST BE OPENED COMPLETELY IN ORDER NOT TO AFFECT THE 3LT FVC TEST

12. 8PRESSING FVC KEY PRESS THE FVC KEY AS TO MAKE AN FVC TEST

13. FOLLOW THE INSTRUCTIONS 9TEST SIMULATION PART. 1

14. 9TEST SIMULATION PART. 2 THE TEST SIMULATION IS MADE OF TWO MANOEUVRES: 1EXPIRATION 2INSPIRATION IN ORDER THAT IT IS SIMILAR TO A NORMAL TEST: -NOT TOO FAST -IN A FEW SECONDS (APPROXIMATELY 3 SECONDS)

15. 2OPEN THE SYRINGE COMPLETELY 1CLOSE THE SYRINGE COMPLETELY 9TEST SIMULATION PART. 3 3CLOSE THE SYRINGE HALF WAY

16. 10OUTPUT INTERPRETATION TAKE NOTE OF THE FOLLOWING VALUES: -FVC CONSIDERING THESE TWO VALUES IT IS POSSIBLE TO DETERMINE WHETHER TO CHANGE THE DEFAULT CALIBRATION SET VALUES -FIVC

17. 11FVC VALUE INTERPRETATION ATS FIXES THE STANDARDS FOR ACCEPTABILITY WITHIN AN ERROR RANGE BETWEEN +3,0%,-3,0%. Min-3,0%Max +3,0% 2,98 3,18 IF THE FVC VALUE ON THE PRINTOUT FALLS IN THE RANGE THE DEVICE SHOULD NOT BE CALIBRATED.

18. 12FIVC VALUE INTERPRETATION PART. 1 USE THE BTPS CORRECTION FACTOR SIGNED ON THE NOTEPAD

19. USE THE BTPS CONVERTION TABLE IN EACH ROW THE BTPS CORRECTION COEFFICIENT CORRESPONDS THE MINIMUM AND THE MAXIMUM FIVC VALUE 12FIVC VALUE INTERPRETATION PART. 2

20. IN EACH ROW THE BTPS CORRECTION COEFFICIENT CORRESPONDS THE MINIMUM AND THE MAXIMUM FIVC VALUE SEARCH FOR THE CORRESPONDENT VALUE ON THE BTPS CORRECTION FACTOR TABLE IN THE BTPS COLUMN 12FIVC VALUE INTERPRETATION PART. 3

21. -FIVC MIN 3,2 -FIVC MAX 3,3 THE BTPS CORRESPONDENT FIVC MINIMUM AND MAXIMUM VALUES ARE : IF THE FIVC VALUE FALLS IN THE RANGE OBTAINED BETWEEN THE MINIMUM AND THE MAXIMUM FIVC VALUES ON THE BTPS CORRECTION COEFFICIENT TABLE THE DEVICE DOES NOT NEED TO BE CALIBRATED 12FIVC VALUE INTERPRETATION PART. 4

22. 13CALIBRATION MENU SELECTION PART. 1 TURN ON THE DEVICE (IF IN THE MEAN TIME THE AUTOMATIC POWER OFF FUNCTION SWITCHED IT OFF)

23. 13CALIBRATION MENU SELECTION PART. 2 SINCE THIS MESSAGE WILL BE DISPLAYED ON THE SCREEN FOR A FEW SECONDS SELECT THE MENU ITEM IMMEDIATELY

24. USE TO SCROLL UP OR DOWN THE MENU 13CALIBRATION MENU SELECTION PART. 3

25. PRESS THE “ON” KEY TO SELECT THE ITEM 13CALIBRATION MENU SELECTION PART. 4 CHOOSE THE NEW CALIBRATION OPTION PRESS THE “ON” KEY TO SELECT THE ITEM

26. THE FVC VALUES AND FIVC VALUES ARE THOSE SHOWN FROM THE LAST SPIROMETRY TEST WITH THE SYRINGE. THESE VALUES CAN BE MODIFIED IF REQUIRED USING AN AVERAGE VALUE FROM 10 TESTS. 13CALIBRATION MENU SELECTION PART. 5 TO INCREASE OR DECREASE A VALUE TO SELECT A VALUE

27. 13CALIBRATION MENU SELECTION PART. 6 THE NEW CORRECTIONS ARE SHOWN ONLY IF THE CORRECTION FACTORS ARE <20% IF THE CORRECTION FACTORS ARE >20% THE DISPLAY SHOWS : “ERROR OUT OF RANGE” INDICATING THAT THE SYSTEM IS NOT ABLE TO CORRECT SUCH A LARGE CALIBRATION ERROR.

28. 14RESTORING DEFAULT CALIBRATION PART. 1 WHENEVER NEW CALIBRATION VALUES ARE INSERTED, THEY CAN ONLY BE REFERRED TO THE CALIBRATED TURBINE. (THE CALIBRATED TURBINE IS THE ONE USED TO PERFORM THE FVC-FIVC TEST WITH THE SYRINGE) MIR TURBINES ARE INTERCHANGEABLE PROVIDED THAT THE FACTORY DEFAULT CALIBRATION IS UNCHANGED. 1 2 3 SWITCH ON THE DEVICE SELECT THE MENU ITEM SELECT THE CALIBRATION ITEM

29. 14RESTORING DEFAULT CALIBRATION PART. 2 THIS MESSAGE IS SHOWN TO CONFIRM THAT THE CORRECTION FACTOR FOR VOLUME AND FLOW (BOTH EXPIRATORY AND INSPIRATORY) IS SET TO ZERO% PRESS THE “OK” KEY TO RETURN TO THE CONFIGURATION MENU CHOOSE THE DEFAULT CALIBRATION OPTION WITH THE FOLLOWING KEYS