iv | Instructions for Use Requirements
Instructions for Use Requirements
This document fulfills the basic needs of persons operating this device, according to the
requirements of the In Vitro Diagnostic Directive for “Instructions for Use.” Some of the
device's higher-level functions and features, as well as certain detailed maintenance and
qualification routines, are described in the Synergy Neo Operator's Manual.
Intended Use Statement
The 800 TS is a single-channel, filter-based absorbance reader designed to perform
measurements of samples in a microplate format. The performance characteristics of the
data reduction software have not been established with any laboratory diagnostic assay.
Users must evaluate this instrument and PC-based software in conjunction with their
specific assay(s). This evaluation must include the confirmation that performance
charactertistics for the specific assay(s) are met.
Quality Control
It is considered good laboratory practice to run laboratory samples according to
instructions and specific recommendations included in the assay package insert for the test
to be conducted. Failure to conduct Quality Control checks could result in erroneous test
data.
Warnings
Operate the instrument on a level, stable surface away from excessive humidity.
Bright sunlight or strong incandescent light can reduce the linear performance
range of the instrument.
Measurement values may be affected by extraneous particles (such as dust) in the
microplate wells. A clean work area is necessary to ensure accurate readings.
When operated in a safe environment according to the instructions in this
document, there are no known hazards associated with the instrument. However,
the operator should be aware of certain situations that could result in serious
injury; these may vary depending on the instrument model. See Hazards and
Precautions.
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