INDEX
1. INTRODUCTION ............................................................................................................................................................................................ 3
1.1 Intended Use ............................................................................................................................................................................................ 3
1.1.1 User Category ...................................................................................................................................................................................... 3
1.1.2 Ability and experience required ....................................................................................................................................................... 4
1.1.3 Operating environment ..................................................................................................................................................................... 4
1.1.4 Subject effect on the use of the device ........................................................................................................................................... 4
1.1.5 Limitations of use - Contraindications ........................................................................................................................................... 4
1.2 Important safety warnings ..................................................................................................................................................................... 4
1.2.1 Danger of cross-contamination ....................................................................................................................................................... 5
1.2.2 Turbine ................................................................................................................................................................................................. 5
1.2.3 Mouthpiece .......................................................................................................................................................................................... 6
1.2.4 Device ................................................................................................................................................................................................... 6
1.3 Unforeseen errors .................................................................................................................................................................................... 6
1.4 Labels and symbols ................................................................................................................................................................................. 6
1.4.1 Identification label .............................................................................................................................................................................. 7
1.4.2 Electrical safety symbol ..................................................................................................................................................................... 7
1.4.3 Warning symbol for the WEEE Directive .................................................................................................................................... 7
1.4.4 Mark of conformity with the Medical Device Directive ............................................................................................................. 7
1.5 Product description ................................................................................................................................................................................. 7
1.6 Technical features .................................................................................................................................................................................... 8
1.6.1 Features of the spirometer ................................................................................................................................................................ 8
1.6.2 Other features ..................................................................................................................................................................................... 9
2. FUNCTIONING OF THE Smart One
®
..................................................................................................................................................... 10
2.1 Connection to PC .................................................................................................................................................................................. 10
2.2 Using the Smart One
®
.......................................................................................................................................................................... 10
2.3 Spirometry Testing ................................................................................................................................................................................ 10
2.4 Spirometry test interpretation ............................................................................................................................................................. 10
3. MAINTENANCE ............................................................................................................................................................................................ 12
3.1 Cleaning and controlling the reusable turbine .................................................................................................................................. 12
4. PROBLEM SOLVING ................................................................................................................................................................................... 12
ANNEX 1 INFORMATION FOR CORRECT USE IN ELECTROMAGNETIC ENVIRONMENTS ....................................... 16
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