SPHERA
REF: ES00001-B
SPHERA UDI-ID: 80536089400722
Up to 200 tests/hour
RANDOM ACCESS EFFICIENCY
Physical characteristics Operation features
REF: ES00001-B SIZE / WEIGHT Height: 49 cm (19.3 in) Weight: 40 kg (83.8 lbs) PIPETTING Volume: sample, 2 - 300 µl; reagent, 5-350 µL
Depth: 60 cm (23.6 in) Precision: 1.5 CV% at 2 µl; 1 CV% at 4 µL
UDI-ID: 80536089400722 Width: 62 cm (24.4 in)
Mixing by sample needle upon dispensation
POWER SUPPLY 100 /240 Vac, 50 /60 Hrz, single phase with ground
Up to 200 tests/hour Independent on-off switch for refrigerated reagent plate
Fuse compartment /fuses: 2.5 Amp @ 230 Vac, 4 Amp @ 115 Vac
REACTION Reaction volume, 210 - 350 µL
Power consumption: less than 200 VA (external PC excluded) SAMPLE In-needle dilution if allowed by method’s sample volumes
Ground resistance: less than 0.1 Ohm DILUTION Automatic pre-dilution in a reaction cuvette, up to 1:100
Leakage current: less than 2.5 mA
TEMPERATURE Reagent refrigeration, about 12 °C below room temperature
SAMPLING ARM 1 sampling needle,110 mm needle stroke CONTROL Reaction cells, heating unit can be set from room
Capacitive liquid level detector temperature up to 42 °C ±0.2 ºC (108 °F ±0.5 ºF)
Needle shock sensor
TYPES OF TESTS Endpoint, Bichromatic endpoint, Differential endpoint,
DILUTER SYRINGE Long life plunger Differential endpoint sample blank, Fixed Time, Kinetic,
Syringe capacity, 368 µL Kinetic bichromatic
Syringe resolution, 0.14 µL
TEST RUNS Random / Urgent (sample attribute)
HYDRAULIC 8 self-priming peristaltic pumps MEASUREMENT 125 tests/hour for double reagent run
SYSTEM with replaceable neoprene tube cassette (life 500 hrs) RATES 200 tests/hour in single reagent mode
2 vacuum pumps Maximum incubation + reading time: 638 seconds
Pinch valve Typical precision, endpoint 2.0 CV% / kinetic 2.0 CV%
Manifold
Containers*: Water, 20L; Cleaning solution, 2L; Waste, 20L START-UP The start-up procedure is run daily: self-test, reader offset of
*equipped with level sensor and safety connections optics, wash and check of all cuvettes
WASH STATION Needles: 6 dispensing, 6 aspiration, 1 cleaning (8 CALIBRATION Reagent blank subtraction, 1 to 8 standards per test method
step washing sequence for each cuvette) cleaning Linear: factor, linear, linear regression
solution on needle 2 Non linear (5 interpolation types): cubic-spline, poly-linear,
multi-parameter, logit-log four parameters and five
REAGENTS TRAY Removable rack parameters
30 bottles, 50 mL or 20 ml (up to 1500 ml total) Free standard / control positions (5 mL tubes or 1 mL cups)
Results can be recalculated when changing factor or
SAMPLES TRAY (Sphera standard) Removable tray, 60 numbered positions, calibration curve
tubes of 12 - 13 mm, 5 - 7 mL / cups of 0.5-1.5 mL (cups
require a metal adapter for level detection) MAINTENANCE Procedures programmed by component life counters
(Optional) Removable tray, 20 + 20 numbered positions,
20 tubes of 12 - 16 mm / 20 cups (3,5 mL type) PRINTING Single test, complete sample, work sheet, method and QCs
REPORTS Automatic sample reports upon test completion if requested
CUVETTE ROTOR 80 washable direct reading cuvettes
REACTION CELLS which allow up to 30 000 tests per rotor NEEDLE Sampling needle washed internally and externally
Optical path 6 mm, 210 - 350 µL reaction volume WASHING with system solution after every operation
100W heating resistance, temperature sensor, safety
thermostat Connections
OPTICAL GROUP 1 halogen lamp (6 V, 10 W) with extended UV emission POWER Standard VDE removable power cord
2 focusing lenses, optical glass EXTERNAL PC USB port
10-position filter disk: 8 positions provided with interference
filters of 340, 405, 505, 546, 578, 600, 650, 700 nm HOST/ LIS Ethernet LAN (samples, work list, results)
wavelengths, Standard ASTM ASCII protocol
1 free position and 1 solid position for dark reading Direct
reading reaction cuvettes, 6mm optical path
Database
±2 nm on peak wavelength, band pass of ±10 nm
WORKLIST/ For each worklist: unlimited number of samples,
PHOTOAMPLIFIER Photoelectric detector SAMPLES unlimited number of tests, up to 99 sheets of
Signal amplifier tests per worklist.
Response range, 340 nm to 900 nm Sample-patient ID codes
Photometric range, 0 to 3 Abs Linearity, Tests archive with powerful search tools
±0.5% from 0.1 to 1.5 Abs Patient management
Precision: 1% CV or 1 mAbs min. (0.1 to 1.5 Abs)
TEST METHODS Unlimited number of methods in PC memory
Stability: daily reader offset, less than 1% drift per day
60 active methods
CONTROL Real-time multitasking microprocessor based control Easy
access to the electronics QUALITY Three-level controls per test, one month monitoring
CONTROL Reagent/calibrator/control lot monitoring,
EXTERNAL (Minimum requirements for Software v.1.5) Exclusion of failing results from graphic and statistics
COMPUTER CPU: Intel i3 or superior
RAM: 8GB ERROR LOG Automatically stored at run-time, can be viewed or printed
SSD: 100GB Hard Disk Powerful on-line monitoring
I/O: USB 2.0 port
Display: minimum resolution 1280x768
OS: Microsoft Windows® 10 or 11
Framework: .NET framework 4.6
