Instructions for use
Calmark POC - Neo
IFU_Calmark_Neo_3-55004-EN_107
3 (15)
17.12 Service .................................................................................................................................. 13
17.13 Technical specification ......................................................................................................... 14
17.14 Performance specification ................................................................................................... 15
2
C
ALMARK
POC
-
N
EO
P
LATFORM
Thank you for choosing Calmark POC - Neo. The product platform provides a fast and easy way to
measure biomarker levels in newborns. Venous whole blood should be used. The system is adapted
to hospital environment and is intended for in vitro diagnostics.
Read this instructions for use before using the device.
2.1
P
RODUCT DESCRIPTION
Calmark POC - Neo consists of an instrument and a single-use test for measurement of bilirubin
levels. The test cassette is constituted by four filters with different functions. The first two filters
which are in contact with the blood are responsible for the blood filtration. Further the plasma will
be separated and migrate through the third filter into the fourth (detection filter) by lateral flow. A
color will appear in the detection filter. A camera, inside the instrument, will take photos during the
test. The color in the detection filter will be analyzed and converted through a software into the
corresponding numeric value of the bilirubin concentration in the blood sample and presented on
the screen. All components are developed and manufactured for maximal security. If the system is
used in a different way than recommended the safety and performance can be compromised.
3
M
ANUFACTURER
Calmark Sweden AB
Sommargatan 101A
656 37 Karlstad
Sweden
For assistance please consult:
