Boston Scientific (User’s Manual Template 8.5in x 11in Global, 91091755 Rev/Ver. AA), Manual, MB, XPS, Global, 50623316-01A_pretrans
Black (K) ∆E ≤5.0
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TABLE OF CONTENTS
1 DEVICE DESCRIPTION ......................................................................................................................................................................................................................3
1.1 Console .....................................................................................................................................................................................................................................3
1.2 FiberLife ....................................................................................................................................................................................................................................3
1.3 Vaporization .............................................................................................................................................................................................................................3
1.4 Coagulation ..............................................................................................................................................................................................................................3
1.5 User Information .....................................................................................................................................................................................................................3
1.6 Contents....................................................................................................................................................................................................................................3
2 INTENDED USE/INDICATIONS FOR USE .......................................................................................................................................................................................3
3 CONTRAINDICATIONS ...................................................................................................................................................................................................................... 4
4 WARNINGS ......................................................................................................................................................................................................................................... 4
5 PRECAUTIONS....................................................................................................................................................................................................................................4
6 ADVERSE EVENTS .............................................................................................................................................................................................................................5
6.1 Some Adverse Events Further Explained ............................................................................................................................................................................ 6
6.2 Complications And Risks By Indication ..............................................................................................................................................................................7
7 HOW SUPPLIED..................................................................................................................................................................................................................................8
7.1 Handling and Storage.............................................................................................................................................................................................................8
8 SAFETY ................................................................................................................................................................................................................................................8
8.1 Eye Injury .................................................................................................................................................................................................................................. 8
8.2 Burns ......................................................................................................................................................................................................................................... 9
8.3 Reflection of the Beam From Instruments ..........................................................................................................................................................................9
8.4 Ignition of Flammable Materials ........................................................................................................................................................................................... 9
8.5 Electrical...................................................................................................................................................................................................................................9
8.6 Operating Room Environment ...............................................................................................................................................................................................9
8.7 Safety Features of the Laser System ................................................................................................................................................................................. 10
9 CONSOLE DESCRIPTION ................................................................................................................................................................................................................11
10 ACCESSORIES ................................................................................................................................................................................................................................13
10.1 Video Camera Insert .......................................................................................................................................................................................................... 13
10.2 Laser Protective Eyewear .................................................................................................................................................................................................13
11 INSTALLATION ...............................................................................................................................................................................................................................13
11.1 Responsibility of BSC .........................................................................................................................................................................................................13
11.2 Responsibility of Customer ................................................................................................................................................................................................ 13
11.3 Positioning of the Console ................................................................................................................................................................................................. 13
11.4 Power Requirements .......................................................................................................................................................................................................... 13
12 INSTRUCTIONS FOR USE .............................................................................................................................................................................................................14
12.1 Touchscreen and Footswitch ............................................................................................................................................................................................ 14
12.2 Preparation ..........................................................................................................................................................................................................................14