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1.2 Intended use
The automated slide stainer FS-16-25 is a device for IN VITRO diagnostics. The
device is designated for the staining of biological preparations on slides. The primary
intended use is histology (particularly – H&E technique) and cytology (particularly –
Papanicolaou stain, for conventional and LBC preparations). The device also can be
successfully used for preparation staining in hematology, microbiology, parasitology.
FORBIDDEN
TO USE THE STAINER FOR ANY PURPOSE OTHER THAN THE
DESIGNATED ONE.
The violation of this requirement may result in accidents, injuries, damages to the
device. The designated use comprises observance of all requirements of the instruction for
use, including observance of the control and maintenance intervals, a routine check of expiry
dates, and quality of reagents. The Stainer performs a chosen technological program
automatically. The manufacturer is not liable to respond if a mistake in programming or
during operation is made, inappropriate reagents are used, the reagents are placed
inappropriately, a program is started with closed lids of troughs, etc.
1.3 Compatibility with reagents and accessories of other manufacturers
The Stainer
is an open system. The programs, supplied with the Stainer, may need
corrections of parameters or changes in programs if used with reagents of other
manufacturers. In most cases, a correction of the duration of technological treatments might
be needed. Staining kits manufactured by MLT LLC are supplied with an operational
instruction with a recommended technological program. The responsibility for independently
compiled programs, for reagents purchased from other manufacturers, or for self-
manufactured reagents is born by the end-user.
FORBIDDEN
TO USE ACCESSORIES AND SPARE PARTS, NOT AUTHORIZED
BY THE MANUFACTURER.
1.4 Qualification of personnel
The FS-16-25 may be operated only by trained laboratory specialists – doctors and
lab technicians. All laboratory personnel designated to operate the Stainer
must read this
instruction for use with all appendices carefully and must be familiar with all technical
features of the Stainer
before attempting to operate it.
FORBIDDEN
TO OPERATE THE STAINER UNLESS THE PERSONNEL HAS
COMPLETED A SAFETY TRAINING, AND
UNLESS READ CAREFULLY THIS
INSTRUCTION FOR USE WITH ALL APPENDICES.