1.3
Obligation to Report Incidents
All serious adverse events occurring in connection with the product must be reported to the manfacturer
and the respective authorities without delay.
1.4
Summary of Safety and Clinical Performance
The summary of safety and clinical performance of the medical device is available in the European
Database on Medical Devices (EUDAMED).
1.5
Notes on this Document
Possible danger to life of patient, user and third parties if these Instructions for Use are not observed
Read and observe the Instructions for Use completely. In particular, be sure to note all cautionary and
warning notices.
This document refers to persons of all genders alike. Reference to individual genders is avoided purely for
reasons of improved readability.
The electronic version of these Instructions for Use can be requested at www.klsmartin.com.
54
Bipolar Sealing System marSeal5 plus/ - Maryland
Instructions for Use
Revision 06