Quality control
Diapath S.p.A. adopts quality management system ISO 9001(*) and ISO 13485(*) to project, make and improve the technical-scientific
solution for the customer in medical and diagnostic in vitro systems, assuring high quality services with the help of highly qualified,
motivated staff to contribute to the improvement of Diapath S.p.A. products.
Diapath S.p.A. constantly strives for customer satisfaction, trying to perceive their expectations and treating the customer without any
discrimination. Diapath S.p.A. assures the application of normative requirements.
Quality assurance of data furnished by Diapath S.p.A. is obtained through these activities:
• Regular use of reference materials
• Performing tests on all production
• Correlation of different results
The internal quality control foresees to monitor the most difficult passages of an analytic process so as to verify their stability, to assure
that quality parameters estimated during the validation or check of the method are valid also for real instruments and that they won’t
deteriorate over time.
Diapath S.p.A. tests its own products in accordance with some internal procedures, to reduce possibility of anomalies during the
operation.
To identify and to find out its own instruments, Diapath S.p.A. uses internal procedures which allows us to find production recording,
assembling recording, tests recording, serial number or batch code and configuration recording.
Instrument information
All information present in this manual only is with regards to the device shown on the cover.
On the instrument rear part, there is the registration plate with the serial number (Image - 1).
Storage and handling
For correct conservation and functioning of the instrument, all the instructions provided in this manual concerning the maintenance and
the installation must be respected.
Also shown below are the environmental requirements that must be respected:
The instrument can work within 80% relative humidity conditions for temperatures up to 31°C with a linear decrease up to 50% at the
temperature of 40°C. Voltage variation can’t exceed +/-10% the nominal value.
The instrument is planned only for internal use and up to 2000 m o.s. altitude
nd transportation temperature range:
Working temperature range:
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