Table of contents
1 Introduction ..................................................................................................................................................... 46
1.1 Abbreviations ............................................................................................................................................. 46
1.2 How to use the Instructions for Use ............................................................................................................. 46
1.3 Significance of warnings and notes .............................................................................................................. 46
1.4 Brief description ......................................................................................................................................... 46
1.5 Intended use .............................................................................................................................................. 47
1.6 Functional description ................................................................................................................................ 47
2. Safety and important information ..................................................................................................................... 48
2.1 Intended purpose ....................................................................................................................................... 48
2.2 Indications and contraindications ............................................................................................................... 48
2.2.1 Side effects and residual risks .............................................................................................................. 49
2.3 Intended user and patient target groups ....................................................................................................... 49
2.3.1 User responsibility ............................................................................................................................... 50
2.4 Important instructions for use and safety ..................................................................................................... 50
2.4.1 General handling of the device .............................................................................................................. 50
2.4.2 Handling recommended accessories .................................................................................................... 51
2.5 Warnings ................................................................................................................................................... 52
2.5.1 Warnings when handling oxygen ........................................................................................................... 54
2.6 Expected service life ................................................................................................................................... 55
2.7 Disclaimer of liability .................................................................................................................................. 55
2.8 Guarantee and warranty ............................................................................................................................. 55
2.9 Adresses ................................................................................................................................................... 55
3 Operation ........................................................................................................................................................ 56
3.1 Preparation ................................................................................................................................................ 56
3.1.1 Précise 6000 MI / MSI – Connections and control elements..................................................................... 56
3.1.2 Installation with Firesafe ...................................................................................................................... 58
3.2 Switching on the device .............................................................................................................................. 59
3.3 Diagnostic mode ........................................................................................................................................ 59
3.4 In operation ............................................................................................................................................... 59
3.4.1 Overview of molecular mode therapy .................................................................................................... 60
3.4.2 Overview of ionisation mode therapy ..................................................................................................... 62
3.4.3 Setting date & time............................................................................................................................... 65
3.4.4 Oxygen therapy - Flow rate ................................................................................................................... 65
3.4.5 Night mode ......................................................................................................................................... 66
3.5 Switching off .............................................................................................................................................. 66
3.6 Oxygen Concentration Supervision .............................................................................................................. 66
3.7 Service & Diagnosis .................................................................................................................................... 66
3.7.1 System settings 1: Device information ................................................................................................... 67
3.7.2 System settings 2: Measured values ...................................................................................................... 68
3.7.3 System settings 3: Error memory ........................................................................................................... 69
4 Malfunctions and their elimination ..................................................................................................................... 70
5 Cleaning Process .............................................................................................................................................. 73
5.1 General information ................................................................................................................................... 73
5.2 Cleaning Intervals ...................................................................................................................................... 74
5.3 Cleaning and Disinfection ........................................................................................................................... 74
6 Maintenance .................................................................................................................................................... 76
7 Pictorial Symbols .............................................................................................................................................. 77
7.1 Definition of the symbols on the device or accessories ................................................................................. 77
7.2 Software symbols ...................................................................................................................................... 78
8 Technical Data and Specifications ..................................................................................................................... 80
9 Storage and Scope of delivery ............................................................................................................................ 81
10 Recommended Accessories, Disposables and Spare Parts ................................................................................ 82
11 Disposal......................................................................................................................................................... 83
Précise 6000 MS / Précise 6000 MSI
Rev.D 2024-10
45