Aggregometer specifications
Automatic optical aggregation system, with internal software, for aggregation tests in PRP or gel filtered or washed platelets with the following attributes:
(I) Features:
(i) Four channel system with optical/turbidometric principle based aggregation, FDA cleared and CE marked.
(ii) Shall have an infra-red based optical system providing high sensitivity preferably with dual-beam detection system calling for platelet count difference of only 75×10 9 /L between test and reference sample for testing.
(iii) Shall have LCD or touch screen display for operator guidance with facility for continuous display of set and the actual temperature of heater block, stirrer speed, selection of PRP/reference, calibration mode with appropriate warning messages and operator alert.
(iv) It should be possible to field upgrade the basic four channel version into an eight channel optical aggregation.
(II) Technical specifications:
Test channel : Four, expandable to eight in field
Lamp source : Infra-red LED
Optics type : Twin well dual infra-red beam
Display : LCD, two or three line, for temperature, stirring, PRP/reference selection, calibration and warning messages
Warning and operator alert for : Automatic baseline setting with over the range detection, prevent operation if stir speed is not within ± 10 RPM, operation stopped if temperature not within ± 0.2°C at the set
temperature
Calibration : Key operated, for optical circuits
Heater block : Temperature electronically controlled 35 to 39°C
selectable within 0.01% accuracy
Incubation wells : Two per channel
Stirrer : 400 to 1200 RPM selectable in steps of 100 RPM and controlled within .01 %
Sample volume : 500 or 250 µl (without spacer)
Software packages : For (i) aggregation testing, (ii) Ristocetin Co-
Factor testing
(III) Software:
Window based data management system to run on a windows based compatible system with featuring:
(a) Should guide the operator with on screen instructions for standard dilutions and running tests.
(b) Calculation of best curve fit for two to six standard dilutions should be available with the copy.
(c) Should allow duplication runs for each standard dilution or test with facility to monitor coefficient of variation between replicates for standards or samples.
(d) It should be possible to rerun or delete a standard dilution, and facility should exist for storage of standard curves for future use.
(e) System software should provide for automatic adjustments of dilution factor with calculation of results in percent activity.
Test:
(a) “Windows XP” or updated version software for ease of operation, and convenient data reduction for aggregation and Ristocetin co-factor assay as standard.
(b) System should be able to display real time graph including amplitude and slope data with possibilities to store and recall the test curves and the associated data.
(c) The facility for computation of slope, amplitude, co-factor activity, coefficient of determination (r 2 ) log time, and area under the curve should all be available.
(e) Reports should be available in standard A4 format with possibility to export data files to spread sheet and or desktop publishing software.
Power: 230V / 50Hz operation