EasyPGX
®
qPCR instrument 96
Cat.Nr: RT800-96
6/21
2017/06
SYMBOLS
Catalogue number (product code)
Manufacturer
Global Trade Item Number
Attention!
Serial number
Hot surface
For
in vitro
diagnostic use
Instrument switched on
European Community
Instrument switched off
Consult the user manual
WEEE mark for Europe
User manual (handbook)
PRODUCT USE LIMITATIONS
▪
“EasyPGX
®
qPCR instrument 96
”
can only be used by specialized personnel, properly instructed and trained.
▪
It is necessary to operate in compliance with the general guidelines of Good Laboratory Practice (GLP) and the
instructions contained in this manual.
▪
“EasyPGX
®
qPCR instrument 96
”
has been validated for use in combination with the "
EasyPGX
®
ready
" kit,
manufactured and commercialized by Diatech Pharmacogenetics srl. The reliability of the results also depends on
the procedures performed in the preliminary phases of the amplification, including the selection of the starting
biological samples, the storage of the samples and the extraction of the nucleic acids.
▪
The results obtained using
“EasyPGX
®
qPCR instrument 96
”
, in combination with "
EasyPGX
®
ready
" kit, are not a
diagnostic report, they must be interpreted by a professional expert, with reference to the clinical history of the
patient, his familiar history and other laboratory tests, in the context of a comprehensive clinical evaluation. Diatech
Pharmacogenetics assumes no responsibility for the clinical decisions taken.
▪
“EasyPGX
®
qPCR instrument 96
”
is covered by CE marking, according to the European Directive 98/79/EC on
in
vitro
diagnostic medical devices (IVD), only in countries that accept the user manual translated into the languages
www.diatechpharmacogenetics.com/area-riservata
QUALITY ASSURANCE
▪
The
“
EasyPGX
®
centrifuge/vortex 1.5 ml
” kit has been designed, developed and validated in compliance with the
Directive 98/79/EC on in vitro diagnostic (IVD) medical devices, transposed in Italy in the D.Lgs No 332/2000 and
s
ubsequent legislative changes, and in accordance with the procedures of the Company’s Quality System certified
for conformance to the European regulatory standards EN ISO 9001 and ISO 13485.
▪
The consistent product quality of
“EasyPGX
®
qPCR instrument 96
”
is guaranteed by the application of a tight
quality control process on operating procedures for the realization of the product and subsequent management to
the customer. The quality of each lot is attested in the Certificate of Analysis available upon request to the Customer
Service (
WARNINGS AND PRECAUTIONS
1. Carefully read this User Manual.
2. If you are not going to use the instrument for an extended period of time, disconnect the power cord from the wall
outlet.
3. The instrument can operate at temperatures between +20°/+30 °C (+65 /+95°F). Do not subject the instrument to
repeated temperature changes.
4. Do not subject the instrument to relative humidity greater than 80% for a prolonged period of time.
5. Any intervention on the instrument can only be performed by Diatech Pharmacogenetics personnel.
Diatech Pharmacogenetics is exempted from any liability if repairs or modifications are made by unauthorized
personnel.
6.
Carry out the procedures for using the instrument and its maintenance according to the
Good Laboratory Practice
(GLP) general guidelines
.
