Thermo Scientific Cryofuge 8 / 16 Centrifuges and Heavy Duty Centrifuges
Preface
vii
Intended Use for Cryofuge 8 / 16 and Cryofuge 16
Heavy Duty
Medical
This centrifuge is intended for separation of blood into blood components using blood bags. The blood components are intended
to be used for human blood transfusion.
Clinical facilities and institutions are responsible for the process of human blood transfusion.
This intended use is limited to the associated rotors and components. Based on the above this centrifuge is a medical device per
European Directive 93/42/EEC. CE marked with Notified Body involvement.
In Vitro Diagnostics
This centrifuge system is intended for separation of blood into cell-free supernatant (plasma, serum) and cell-containing sediment.
Plasma and serum are intended to be used in In-Vitro Diagnostic (IVD) applications (assays).
Blood is used in numerous diagnostic tests such as hematological screening (e.g. measurement of free hemoglobulin),
immunological screening (e.g. measurement of thrombocytes levels) and cardiovascular system assessment.
Self declared, CE marked without Notified Body involvement.
Intended User
The centrifuge must be operated by trained personal only.
Trained personnel can be a clinical laboratory technologist, a medical laboratory technician or personal with similar education.
Associated Rotors and Components
The Thermo Scientific
™
Cryofuge 8 centrifuge can be operated with the Thermo Scientific
™
HAEMAFlex
™
6 and HAEMAFlex 8
rotor. The Thermo Scientific Cryofuge 16 and Thermo Scientific Cryofuge 16 Heavy Duty centrifuge can be operated with the
Thermo Scientific HAEMAFlex 12 and HAEMAFlex 16 rotor. For more details on buckets and further components: