Hardware User (IVD) Instruction Manual

Luminex IVD MAGPIX Hardware Installation and User Manual
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Operating altitude: up to 2400m (7874 ft) above mean sea level
Shipping temperature: 0-50°C (32-122°F)
Storage temperature: 10-40°C (50-104°F)
Electronics
USB 2.0-compatible communications link for fast data transfer
Input voltage range: either 100-120 V~, 2.0 A 50/60 Hz or 200-240 V~, 1.0 A 50/60 Hz
Optics
Reporter channel detection: A/D resolution 16 bits
Reporter detector: CCD, detection bandwidth of 566 to 614 nm
Classification detector: CCD
Limit of Detection (LOD): For the reporter channel, using a blank microsphere from
region 078, 700 molecules of phycoerythrin (PE) per microsphere
Dynamic Range: For the reporter channel, using a microsphere from region 078, 3.0
decades
Efficiency: Classification Channels: 80%
Fluidics
Sample load rate: 20 L to 500 L per second
Sample uptake volume: 20 to 200 L
Well-to-well carryover: < 4%
Sample uptake accuracy: +/- 5%
Microtiter Plates
Microtiter plate must be 96-well, not to exceed 1” (2.54cm) in height, including heater
block.
Microtiter plate must be compatible with the microtiter heater block temperature when
the heater block is in use.
All microtiter plates have standard width (85.5mm) and length (127.9 mm). Depth
varies depending on the type of well. Maximum allowable depth is 1” (2.54cm). Plates
must have minimum 0.06” (1.5mm) lip height, standard distance from well center to
well center (9mm) and standard distance from A1 center to plate center in both length
and width. To be compatible in size with the microtiter heater block, the plate must fit
into the heater block so that the top is flush with the heater block.
Microspheres
Distinguishes 1 to 50 unique MagPlex microspheres in a single sample
Misclassification Rate 2%
Classification Rate 80%
Detects and distinguishes surface reporter fluorescence emissions at 590 nm +/- 24
nm on the surface of 1 to 50 unique MagPlex microsphere in a single sample
Soluble background fluorescence emission at 590 nm +/- 24 nm automatically
subtracted from fluorescence intensity values