spinit® System
Intended Use
spinit® is for
in vitro
diagnostic use only, consisting of an instrument and discs targeting specific
treatment monitoring conditions. The system is used by healthcare professionals in a variety of
healthcare settings, and exclusively with spinit® discs and recommended controls.
Conformity to the IVD directive
The spinit® instrument meets all provisions in the European directive 98/79/EC on
In Vitro
Diag-
nostic Medical Devices and is CE marked accordingly.
Safety standards
The spinit® instrument has been tested and found to be in conformity with IEC 61010
-
2
-
101:2018
(Particular requirements for
in vitro
diagnostic (IVD) medical equipment).
EMC standards
The spinit® instrument has been tested and found to be in conformity with EMC IVD instrument
standard EN 61326
-
2
-
6:2013 (
In vitro
diagnostic (IVD) medical equipment).
Rua 25 de Abril nº66,
2050
-
317 Azambuja, Portugal
ISO13485 certified company
2
spinit® User Manual
