User's Manual

ManualsBrandsMIR Medical International Research ManualsElectronicsSpirobank with Bluetooth SMART

Spirobank II

Page 2 of 34

Rev.1.1

User manual

INDEX

1. INTRODUCTION .............................................................................................................................................................................................. 4

1.1 Intended use ............................................................................................................................................................................................ 4

1.1.1 User category ........................................................................................................................................................................................... 4

1.1.2 Ability and experience required .................................................................................................................................................................... 4

1.1.3 Operating Environment ............................................................................................................................................................................. 4

1.1.4 Homecare usage ........................................................................................................................................................................................ 4

1.1.5 Patient effect on the use of the device ........................................................................................................................................................... 5

1.1.6 Limitations of use - Contraindications .......................................................................................................................................................... 5

1.2 Important safety warnings .......................................................................................................................................................................... 5

1.2.1 Danger of cross-contamination.................................................................................................................................................................... 5

1.2.2 Turbine ................................................................................................................................................................................................... 6

1.2.3 Mouthpiece .............................................................................................................................................................................................. 6

1.2.4 Oximetry sensors ...................................................................................................................................................................................... 6

1.2.5 Device..................................................................................................................................................................................................... 7

1.3 Lithium-ion battery pack warning................................................................................................................................................................. 7

1.4 Labels and symbols ................................................................................................................................................................................... 9

1.4.1 Identification label ..................................................................................................................................................................................... 9

1.4.2 CE mark for medical devices ....................................................................................................................................................................... 9

1.4.3 Electrical safety symbol ............................................................................................................................................................................ 10

1.4.4 Warning symbol for the USB .................................................................................................................................................................... 10

1.4.5 Warning symbol for the SpO2 port for oximetry .......................................................................................................................................... 10

1.4.6 Warning symbol for the WEEE ................................................................................................................................................................. 10

1.4.7 FDA and FCC Warnings .......................................................................................................................................................................... 10

1.4.8 (ESD) Electrostatic discharge sensitivity symbol ........................................................................................................................................... 10

1.4.9 Information regarding the protection against the ingress of liquids................................................................................................................... 11

1.4.10 Symbol for devices that include RF transmitter ........................................................................................................................................ 11

1.5 Product description ................................................................................................................................................................................. 11

1.6 Technical specification ............................................................................................................................................................................. 12

1.6.1 Features of the spirometer ........................................................................................................................................................................ 13

1.6.2 Oximeter features.................................................................................................................................................................................... 13

1.6.3 Other features ........................................................................................................................................................................................ 14

2. FUNCTIONING OF THE SPIROBANK II ......................................................................................................................................................... 14

2.1 switch on and switch off the device ............................................................................................................................................................ 14

2.2 Energy saving ......................................................................................................................................................................................... 15

2.3 Main screen ............................................................................................................................................................................................ 15

2.4 Symbols and Icons .................................................................................................................................................................................. 15

2.5 Service menu .......................................................................................................................................................................................... 16

2.5.1 Turbine calibration .................................................................................................................................................................................. 18

2.6 Patient Data ........................................................................................................................................................................................... 19

2.6.1 Inserting data of a new patient ................................................................................................................................................................... 20

2.6.2 Patient data modification .......................................................................................................................................................................... 20

2.7 Visualization of memory data .................................................................................................................................................................... 20

2.7.1 Database research modality ....................................................................................................................................................................... 20

2.7.2 Visualization of database info .................................................................................................................................................................... 21

2.8 On line mode ......................................................................................................................................................................................... 21

2.9 Spirometry testing ................................................................................................................................................................................... 21

2.9.1 FVC test ................................................................................................................................................................................................ 22

2.9.2 POST test, after drug administration .......................................................................................................................................................... 22

2.10 Viewing the spirometric results .................................................................................................................................................................. 23

2.10.1 Spirometry test interpretation ............................................................................................................................................................... 23

2.11 Oximetry Testing .................................................................................................................................................................................... 24

2.11.5 Instructions for Adult Single Patient Sensor ............................................................................................................................................ 26

3. DATA TRANSMISSION .................................................................................................................................................................................... 27

3.1 PC connection via USB port ..................................................................................................................................................................... 27

3.2 Internal software upgrade ......................................................................................................................................................................... 27

4. MAINTENANCE ............................................................................................................................................................................................. 27

4.1 Oximetry sensor cleaning ......................................................................................................................................................................... 27

4.2 Changing the adhesive wrap sensor ............................................................................................................................................................ 28

4.3 Battery charging ...................................................................................................................................................................................... 28

5. PROBLEM SOLVING ....................................................................................................................................................................................... 28

LIMITED WARRANTY CONDITIONS ..................................................................................................................................................................... 31

ANNEX 3 INFORMATION FOR CORRECT USE IN AN ELECTROMAGNETIC ENVIRONMENT ..................................................................... 32