Table of Contents
1 User Information ..................................................................................................... 5
1.1 Using this Instruction Manual ................................................................................ 5
1.2 Icons .................................................................................................................. 5
1.2.1 General Symbols ............................................................................................. 5
1.2.2 Device and Packaging ...................................................................................... 5
1.2.3 Display ........................................................................................................... 6
1.3 Symbol Convention .............................................................................................. 6
1.4 Glossary ............................................................................................................. 6
1.5 Intended Use ....................................................................................................... 7
1.5.1 Essential Features ............................................................................................ 7
1.5.2 Indications ...................................................................................................... 7
1.5.3 Contraindications ............................................................................................. 7
1.5.4 Restrictions on use .......................................................................................... 7
1.6 Basic Safety Instructions ....................................................................................... 8
1.7 User Requirements ............................................................................................... 9
1.8 Information on Product Liability ............................................................................. 9
1.9 Material Compatibility ........................................................................................... 9
2 Product Description ............................................................................................... 10
2.1 Whole View ........................................................................................................ 10
2.1.1 simex cuff M .................................................................................................. 10
2.1.2 simex cuff M product contents .......................................................................... 10
2.1.3 simex cuff S ................................................................................................... 11
2.1.4 simex cuff S product contents .......................................................................... 11
2.2 Product Properties ............................................................................................... 12
2.2.1 Disposable secretion canister for simex cuff M .................................................... 12
2.2.2 Information on the simex filter system for the simex cuff M ................................. 12
2.2.3 Information on the carbon filter of the simex cuff M ............................................ 13
2.2.4 Disposable secretion canister system for simex cuff S ......................................... 13
2.2.5 Information on the double filter system for simex cuff S ...................................... 13
2.2.6 Battery .......................................................................................................... 14
2.2.7 Pressure settings ............................................................................................ 14
2.3 Warranty ........................................................................................................... 14
3 Operation .............................................................................................................. 15
3.1 Set-Up and Startup ............................................................................................. 15
3.1.1 Startup ......................................................................................................... 15
3.1.2 Connecting the simex cuff M and simex cuff S .................................................... 16
3.1.3 Positioning of the simex cuff M ......................................................................... 16
3.1.4 Connecting the disposable secretion canister (250 ml) of the simex cuff M ............. 17
3.1.5 Positioning of the simex cuff S ......................................................................... 17
3.1.6 Connecting the simex disposable secretion canister system of the simex cuff S ...... 17
3.1.7 Connecting endotracheal and tracheal tubes with integrated suction port .............. 19
3.2 Operation of the simex cuff M and simex cuff S ...................................................... 19
3.2.1 Setting the run and pause time ........................................................................ 20
3.2.2 Language selection ......................................................................................... 21
3.3 Patient Mode ...................................................................................................... 22
3.4 Canister Replacement ......................................................................................... 23
3.4.1 Replacement of the disposable canister (250 ml) of the simex cuff M .................... 23
3.4.2 Replacement of the disposable liner (1,000 ml) of the simex cuff S ....................... 23
4 Maintenance .......................................................................................................... 24
4.1 Cleaning and Care ............................................................................................... 24
4.1.1 General Information ........................................................................................ 24
4.1.2 Cleaning and disinfection of the surface of the device .......................................... 24
4.1.3 Disposal of the disposable secretion canister for simex cuff M .............................. 25
4.1.4 Disposal of the disposable liner and the suction tube for simex cuff S .................... 25
4.1.5 Cleaning / disinfection of the external canister for simex cuff S ............................ 25
4.1.6 Cleaning / disinfection of the tubing accessories for simex cuff S .......................... 25
4.2 Maintenance and Service ..................................................................................... 25
4.3 Testing of the simex cuff M or simex cuff S ............................................................ 26
5 Problem Solving .................................................................................................... 26
5.1 Function Test ...................................................................................................... 26
5.2 Troubleshooting .................................................................................................. 26
5.3 Error Messages ................................................................................................... 27
6 Transport, Storage and Disposal............................................................................ 28
6.1 Decontamination prior to Shipment ....................................................................... 28
