spinit® User Manual | Instrument system descripon 6
How the spinit® instrument works
The spinit® instrument is a stand-alone, small benchtop in vitro medical device intended to deliver
a diagnosc plaorm designed for the Point-Of-Care Tesng market.
The spinit® system is based on a proprietary technology integrang a single plaorm for point of
care diagnoscs. It is designed to oer rapid results from a single drop of blood, providing fast,
safe and eecve clinical monitoring and improved paent care. The instrument is designed to be
a universal, mul-assay instrument plaorm capable of accommodang dierent tests developed
to address the most urgent needs in the clinic.
Two versions of the spinit® instrument are currently CE marked.
The spinit® S40 is the complete version of the spinit® instrument and is designed to include all ana-
lycal modules enabling the customer to run all three types of spinit® tests currently available on
the market, the spinit® CRP (measures C-Reacve Protein levels in whole blood), spinit® HbA1c
(measures glycated haemoglobin A1c concentraon in whole blood and BC (measures total white
blood cell count and 5-part dierenal with the opon of haematocrit quancaon).
The spinit® E40 is the Essenal version of the spinit® instrument and only reads spinit® CRP and
spinit® HbA1c discs.
Both spinit® S40’s and E40´s analycal module are comprised of a spectrophotometer. The spec-
trophotometer is made up of two light eming diodes (LEDs), two photodiodes that funcon as
detectors and an electronic circuit board that processes the LEDs independently. Emied light is
reected inside the disc and passes through a detecon chamber. Transmiance of light through
the opcal path is measured and will vary depending on the reacon occurring inside the cham-
ber. The transmission of light through the blood sample in the detecon chamber is measured and
is correlated to the concentraon of the specic analyte. The instrument accepts several types of
spinit® discs. The analycal process is fully automated and the completed test results are shown
on the screen. In addion, only the S40 integrates a microscopy module for image acquision and
a precise angular disc posioning module. The microscopy module is composed by the following
components: illuminaon stage, miniaturized microscope with auto-focus capability and a digital
camera. Moreover the soware version must include new features: remote control of disc angular
posion and auto-focusing funcon, digital image treatment (illuminaon correcons, background
correcon, etc.), object detecon within a image (segmentaon) and WBC feature analysis and
classicaon. It will also include a soware feature to allow for haematocrit measurements based
on RBC sedimentaon by centrifugal blood/plasma separaon.
The barcode on the pouch label prompts the instrument to conduct the appropriate test.
The instrument is delivered to the user pre-calibrated. If the instrument detects a malfuncon, the
test will be interrupted with a display of the informaon code and the paent results will not be
reported. The user must refer to the spinit® User Manual to understand the cause of the infor-
maon code.