1.
INTRODUCTION .................................................................................................................................................................................................. 6
1.1
Intended use ................................................................................................................................................................................................... 6
1.1.1
User category ............................................................................................................................................................................................ 6
1.1.2
Ability and experience required ............................................................................................................................................................. 6
1.1.3
Operating Environment .......................................................................................................................................................................... 6
1.1.4
Who can or must make the installation ................................................................................................................................................ 6
1.1.5
Patient effect on the use of the device ................................................................................................................................................. 6
1.1.6
Limitations of use - Contraindications ................................................................................................................................................. 7
1.2
Important safety warnings ........................................................................................................................................................................... 7
1.2.1
Danger of cross-contamination ............................................................................................................................................................. 8
1.2.2
Turbine ....................................................................................................................................................................................................... 8
1.2.3
Mouthpiece ................................................................................................................................................................................................ 8
1.2.4
Oximetry sensors ..................................................................................................................................................................................... 8
1.2.5
USB connection cable ............................................................................................................................................................................. 9
1.2.6
Device ........................................................................................................................................................................................................ 9
1.2.7
Warnings for use in electromagnetic environments ........................................................................................................................10
1.3
Lithium-ion battery pack warning ............................................................................................................................................................10
1.4
Unforessen errors ........................................................................................................................................................................................11
1.5
Labels and symbols .....................................................................................................................................................................................11
1.5.1
Identification label and symbols ..........................................................................................................................................................11
1.5.2
Symbols used ..........................................................................................................................................................................................11
Warning symbol for the WEEE ...........................................................................................................................................................................12
1.5.3
FDA and FCC Warnings ......................................................................................................................................................................12
1.5.4
(ESD) Electrostatic discharge sensitivity symbol .............................................................................................................................13
1.6
Product description .....................................................................................................................................................................................13
1.7
Technical specification ...............................................................................................................................................................................14
1.7.1
Features of the spirometer....................................................................................................................................................................15
1.7.2
Oximeter features ...................................................................................................................................................................................15
1.7.3
Oximetry alarms description ................................................................................................................................................................19
1.7.4
Other features .........................................................................................................................................................................................20
2.
FUNCTIONING OF THE SPIRODOC .........................................................................................................................................................21
2.1
Display...........................................................................................................................................................................................................21
2.2
Switching on and off the Spirodoc ..........................................................................................................................................................21
2.3
PIN request ..................................................................................................................................................................................................22
2.4
Energy saving ...............................................................................................................................................................................................22
2.5
Main screen ..................................................................................................................................................................................................23
2.6
Symbols and Icons ......................................................................................................................................................................................23
2.7
Service menu ................................................................................................................................................................................................24
2.7.1
Doctor Mode ..........................................................................................................................................................................................24
2.7.2
Patient Mode ...........................................................................................................................................................................................29
2.7.3
Reusable turbine calibration .................................................................................................................................................................30
2.8
Patient Data ..................................................................................................................................................................................................31
2.8.1
Inserting data of a new patient ............................................................................................................................................................31
2.8.2
Patient data modification ......................................................................................................................................................................32
2.9
Visualization of memory data ...................................................................................................................................................................32
2.9.1
Database research modality ..................................................................................................................................................................32
2.9.2
Visualization of database info ..............................................................................................................................................................33
2.10
Display of last test session from current patient ...................................................................................................................................34
2.11
PC On line mode (connected to a PC) ....................................................................................................................................................34
2.12
Spirometry testing .......................................................................................................................................................................................34
2.12.1
FVC test ...................................................................................................................................................................................................35
2.12.2
Test VC ....................................................................................................................................................................................................35
2.12.3
MVV Test ................................................................................................................................................................................................36
2.12.4
POST test, after drug administration..................................................................................................................................................36
2.13
Viewing the spirometric results ................................................................................................................................................................36
2.13.1
Spirometry test interpretation ..............................................................................................................................................................36
2.14
Oximetry Testing ........................................................................................................................................................................................38
2.14.1
Walk test (6MWT)..................................................................................................................................................................................40
2.14.2
Sleep Oximetry .......................................................................................................................................................................................42
2.14.3
Oximetry SpO2/BPM ...........................................................................................................................................................................42
2.14.4
Patient mode oximetry ..........................................................................................................................................................................42
2.14.5
Instructions for Adult Patient Sensor .................................................................................................................................................43
2.15
Testing without patient data ......................................................................................................................................................................44
3.
DATA TRANSMISSION .....................................................................................................................................................................................44
3.1
Printing a test ...............................................................................................................................................................................................44
3.1.1
How to print a test saved in the database ..........................................................................................................................................44
SPIRODOC
INDEX
cod. 980156
Rev 4.2.1
spirodoc
User manual
EN 2/48