TELEMED ClarUs User Guide, REV 4.0 2013.12.04
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2. Vigilance system
This equipment is subject to the TELEMED vigilance system (post-marketing vigilance) in
casse of potential or real hazards for the patient or for the operator which might occur during normal
system functioning, in order to be able to remove them with the best efficiency and timing.
Therefore, if a user records any malfunction or deterioration in the characteristics and/or
performances of the device, as well as any inadequacy in the labeling or the instructions for use which
might lead to potential or real hazards for a patient or for an operator, we kindly request that you
immediately
inform the TELEMED office or local Competent Authority or our official dealer/distributor
including sending us the following form (or reporting the same data contained in this form in some
other manner) and
do not use
this device. All data relating to the system can be found on its
identification label. In this way we will be able to take all adequate, opportune and effective actions.
Post-Marketing Vigilance Form
To: Quality Assurance Department
UAB "TELEMED"
Dariaus ir Gireno str. 42
Vilnius LT-02189
Lithuania
Phone1: (+370-5) 2106272
Phone2: (+370-5) 2106273
Fax: (+370-5) 2306733
System/device name ________________________________________
Serial number _____________________________________________
Description of potential hazard ________________________________
_________________________________________________________
Notes and suggestions ______________________________________
_________________________________________________________
Contact person/ Department __________________________________
Address __________________________________________________
Phone _________________________ Fax _____________________
Email __________________________
Date _____________________ Signature ________________
