3 Introduction
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M e d i z i n i s c h e
L a b o r d i a g n o s t i k a
A G
EUROIMMUN
3 Introduction
This document is used to explain the Sprinter XL. After familiarising himself with
this manual, the operator should be able to operate the Sprinter XL safely.
Figures and illustrations may deviate slightly, depending on the configuration of
the instrument.
3.1 Intended
use
The Sprinter XL provides fully automated processing of microscope slides for
indirect immunofluorescence, from sample preparation to the final washing step.
ELISA and EUROASSAYS for in vitro determination of human autoantibodies in
serum or plasma in autoimmune diagnostics, infectious serology and allergology
may also be processed with this device. The test systems are provided by
EUROIMMUN AG. The system was developed for use in diagnostic institutions.
The results should always be checked for correctness by medically qualified
personnel. For diagnosis, the clinical symptoms of the patient should always be
taken into account along with the serological findings.
The instrument should be operated in a fixed place under laboratory conditions
and can be used several times a day. The instrument should only be used by
trained personnel.
For IVD compliant use of the Sprinter XL, all test methods and kits must be
validated by the user in conjunction with the device. Here the usual clinical
laboratory practice, locally applicable laws and the current state of the art are to
be observed.
3.2 Validation
Proper functioning of the instrument was tested using representative test systems
from EUROIMMUN AG.
Changes of any kind to the Sprinter XL, the software or the firmware
invalidate the warranty for the instrument and result in the loss of IVD
conformity.
Only CE-labelled test kits may be used for clinical diagnostic applications.
