KLS Martin group marVac Instructions For Use Manual page 32

Table of Contents
1 General ...................................................................................................................................................... 34
1.1 Manufacturer ................................................................................................................................... 34
1.2 Hotline .............................................................................................................................................. 34
1.3 Adverse incident reporting requirement ......................................................................................... 35
1.4 Summary of safety and clinical performance .................................................................................. 35
1.5 Safety warnings used in this document ........................................................................................... 35
1.6 Abbreviations and Terms ................................................................................................................. 36
1.7 Validity of this document ................................................................................................................. 36
1.8 Accompanying Documents .............................................................................................................. 36
2 Scope of delivery ....................................................................................................................................... 37
2.1 Inspection of the delivery for completeness and correctness ......................................................... 37
3 Intended use .............................................................................................................................................. 38
3.1 Purpose ............................................................................................................................................ 38
3.2 Indications ........................................................................................................................................ 38
3.3 Contraindications ............................................................................................................................. 38
3.4 Clinical benefit .................................................................................................................................. 38
3.5 Possible adverse effects ................................................................................................................... 38
3.6 Target patient population ................................................................................................................ 38
3.7 Users ................................................................................................................................................ 38
3.8 Environmental conditions during use .............................................................................................. 38
3.9 Restrictions on use ........................................................................................................................... 39
3.10 Warnings .......................................................................................................................................... 39
3.11 IT safety ............................................................................................................................................ 39
4 Mounting / Installation ............................................................................................................................. 39
5 Operation/Use/Application ....................................................................................................................... 42
5.1 Setup menu ...................................................................................................................................... 42
5.2 Activation of the line current detection function ............................................................................ 46
5.3 Calibration ........................................................................................................................................ 47
5.4 Configuration of the switch-on delay time ...................................................................................... 48
5.5 Configuration of the switch-off threshold ....................................................................................... 51
6 Cleaning, disinfection, and sterilization .................................................................................................... 53
6.1 Inspection, Functional Check, Maintenance .................................................................................... 53
6.2 Packaging ......................................................................................................................................... 53
6.3 Sterilization ...................................................................................................................................... 53
6.4 Storage and transport ...................................................................................................................... 54
7 Maintenance ............................................................................................................................................. 55
7.1 General Notes .................................................................................................................................. 55
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marVac® / maXium® smart Vac iDetect external line current detector
Instructions for Use
Revision 04