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Device name:

Date of manufacture:

Type designation:

LOT

Your distributor:

Customer / department:

1. Putting the device into operation 1. Putting the device into operation 1 2 3

2. Clarity of the instructions for use 2. Clarity of the instructions for use 1 2 3

3. Clarity of labels, graphic symbols and markings 3. Clarity of labels, graphic symbols and markings 1 2 3

4. Dimensions of the device 4. Dimensions of the device 1 2 3

5. Catheter length 5. Catheter length 1 2 3

6. Presence of VICHR element 6. Presence of VICHR element 1 2 3

7. Spray parameters 7. Spray parameters 1 2 3

8. Clinical efficacy and safety when used in accordance with the approved purpose 8. Clinical efficacy and safety when used in accordance with the approved purpose 1 2 3

9. Occurrence of adverse events An adverse event of a medical device means: a) any failure or deterioration of the properties or effectiveness of the medical device or inaccuracy in the labeling of the medical device or in the instructions for use, which have led or could lead to the death of the user or another individual or to a serious deterioration of their health. b) a technical or medical reason that is related to the properties or effectiveness of the medical device and leads the manufacturer, for the reasons listed in a) hereinabove, to systematically withdraw the medical device of the same type from the market. 9. Occurrence of adverse events An adverse event of a medical device means: a) any failure or deterioration of the properties or effectiveness of the medical device or inaccuracy in the labeling of the medical device or in the instructions for use, which have led or could lead to the death of the user or another individual or to a serious deterioration of their health. b) a technical or medical reason that is related to the properties or effectiveness of the medical device and leads the manufacturer, for the reasons listed in a) hereinabove, to systematically withdraw the medical device of the same type from the market. Yes No