Docon
®
7
Intended use
Page 14 of 74
2
Intended use
2.1 Proper use - intended use
The Docon 7 is a medical device and serves to mix the blood during a blood donation with
the anticoagulant in the blood bag and to stop the blood supply once an adjustable volume
has been reached. In addition, internal information on the donation as well as external data
entered by the user can be collated and transferred to an EDP system.
Only those who fulfil the general criteria for blood donations are permitted to donate blood,
e.g. "Guidelines for the Preparation of Blood and Blood Components and for the Use of
Blood Components" and "Guide to the preparation, use and quality assurance of blood
components".
2.2 Combination with other products
Blood bag systems are necessary to allow blood to be donated. The Docon 7
may only be operated with bag systems which satisfy all the statutory require-
ments made of blood bag systems.
Furthermore, the max. capacity of the bag systems must not exceed 1000 ml.
2.3 Essential performance features
The Docon 7 does not have any essential performance features.