1
Introduction
1.1 - Intended use of device
Automated analyser for in vitro determination of the Erythrocyte Sedimentation Rate (ESR) of human blood
samples in conformity with the Westergren standard.
For professional use in medical laboratories only. To be used for all patient populations, not restricted by age
or any other anatomical or physiological particulars.
1.2 - Indication for use of device
For screening and follow-up of patients with (suspected) inflammatory conditions.
1.3 - Instrument overview
The Starrsed Blood Sedimentation Rate Instrument (hereafter called Interrliner) is an
medical device that automatically carries out the
erythrocyte sedimentation rate
(ESR) analysis according to
the Westergren method, conforming to CLSI approved standard H02-A5
1
and recommended by the ICSH
2
,
using closed sample tubes filled with citrate or EDTA blood.
The Interrliner is an advanced ESR system that offers many unique features and benefits over the traditional
ESR procedures. Automating this method has the following advantages:
▪
The Westergren pipettes are always filled to the correct level.
▪
Using closed sample tubes reduces the possibility of contamination for the user and environment.
▪
Standard glass Westergren pipettes are used, in which the measurement can be corrected to a constant
temperature (18 °C Celsius). Even small abnormalities can be detected over a longer period of time,
irrespective of where and when the blood sample was taken.
▪
Sample ID's are read by the barcode reader and each sedimentation measurement is linked to the
identified sample, so that a manual work sheet is unnecessary.
▪
In the
, the dilution of EDTA blood with citrate is considerably more accurate than manual
dilution achieved either by "tipping off" or using evacuated blood collection tubes pre-filled with citrate
solution.
▪
The data can be send to your Lab Information System (LIS/LIMS)
▪
The used sedimentation pipettes are automatically washed and dried.
▪
Minimum sample volume is 1.4 ml for the Interrliner.
▪
The Interrliner integrates with the Sysmex HST - XN line.
This model Interrliner is delivered with a front return line and uses the Sysmex sample racks.
The advanced software allows the Interrliner to communicate with the Sysmex Lab Comm host computer
systems.
References:
(1) CLSI Procedures for the Erytrhocyte Sedimentation Rate Test: Approved Standard - Fifth edition H02-A5,
VOl. 31 No 11; 2011
Introduction
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MRN-164_2-EN Version 2.02 Interrliner