Hettich AG, Seestrasse 204a, 8806 Baech, Switzerland
Operator_Manual_Rotolavit II_und_Rotolavit II-S_en_rev2.5
Seite 9
2 Use according to the specifications
The present device is a wash centrifuge intended for in-vitro diagnostic applications, in accordance with
“Directive 98/79 EC”. The sample processing with the use of the device and the corresponding inserts is realised
by the filling with a washing liquid and subsequent shaking, centrifuging and decanting. The device itself is used
for sample processing and not for sample analysis.
The following device types are available for this device:
Rotolavit II, Type 1008-00 and 1008-03
These device types are used to wash respectively to clean erythrocytes for carrying out quick anti-human globulin
tests (direct and indirect Coombs tests) in crossmatch, antibody screening and differentiation.
Leukocytes can be washed in the same way to prepare samples for tuberculosis or tumour testing. The device
is intended exclusively for the applications mentioned and is only allowed to be used in closed clinical
laboratories by medically trained specialists.
Rotolavit II-S, Type 1008-00S
This device type is used to wash respectively to clean blood or other cell-containing samples to prepare the flow
cytometric analysis on a sample preparation system and flow cytometer. The process steps can be individually
configured by the user and stored in the device. The configured process steps are processed automatically by
the device. A wash-cycle may consist of several processes in which the samples are centrifuged, the
supernatant decanted, and then each sample tube is filled with a physiological saline solution and mixed.
The device should only be used by trained medical personnel in clinical laboratories and used only for the stated
purpose.
The life cycle of the device specified by the manufacturer is seven years. The lifetime of some parts of the
accessories is divergent and is specified in chapter 12.10 of this manual.
Any other use beyond this purpose, as well as non-observance of the intended use (see instructions in the
operating instructions regarding transport, storage and execution of cleaning, inspection and maintenance
work) is considered to be improper use. The company Hettich AG accepts no liability for any damage arising
from this.
2.1 Versions
The device is available in different configurations. If specific equipment features or functions are available only for
certain configurations, this is indicated at the relevant points in this manual. The functions described in this manual
refer to the latest software version. This manual was written in accordance with the software-version 1.01.421.
2.2 Storage and forwarding the operator-manual
This instruction manual belongs with the device and should always be stored where persons working on the
device have access to it. It is the responsibility of the owner to ensure that persons who are working or will work
on the device are informed as to the whereabouts of this operator manual. We recommend that it is always stored
in a protected location close to the device. Make sure that the instruction manual is not damaged by fluid or
humidity. If the device is sold on or transported and then set up again at a different location, the operator manual
must go with it.
