TRANSFUSION MEDICINE Technical specifications Environmental requirements and dimension ELECTRICAL REQUIREMENTS Functional specifications SAMPLE STATION Voltage 100-240 V Load capacity up to 72 tubes simultaneously Frequency 50-60 Hz Loading system Maximum input power consumption 600 W up to 6 removable holders with 12 positions/each Yes Consumption in inactive state 30 VA Continuous sample loading and unloading Fuses 2 x T6.3AL 250V, 5x20 mm Emergency sample management Yes Protection against electric shocks Class I Sample containers Installation category Overvoltage category II (local levels, instruments, portable equipment, etc.) Generically, plastic or glass tubes with the following dimensions: 9 ≤ Ø ≤ 16 mm and length ≤ 100 mm Adaptors for sample tubes No, except for pediatric tubes (same Erytra® pediatric rack: 16,5cmx5,5cmx9,5cm) Positioning of the samples Continuous and random Number of probes 1 probe Level detection Yes, on the probe Clot detection for samples Yes, on the probe Sample dilution Yes, by using the DG Gel Sol diluent in a dilution station with a self-washing cup Positive sample identification Yes Sample barcode type Interlaced 2 of 5 Code 3 of 9 Codebar EAN8/EAN 13/JAN8/JAN 13 Codes 128 A, B & C (ISBT 128) Others under configuration DIMENSIONS Height 91 cm Width 110 cm (without monitor) Depth 71 cm Weight Approximately 173 kg Weight with packaging Approximately >193 kg OPERATING CONDITIONS Temperature 15°C to 30°C Maximum relative humidity non-condensing 85% Maximum altitude 3,000 m Protection against electric shocks Class I Contamination grade 2 Power supply maximum voltage fluctuations ±10% of the nominal voltage TYPING LIQUID REAGENT STATION 16-0042 SYSTEM AND WASTE SOLUTIONS Reagent positions Up to 46 liquid reagents (34 RRBC + 2 DG Gel Sol + 10 liquid antisera) Reagent agitation Yes, up to 34 positions (RRBC) Reagent loading system Through 2 removable racks continuous access lineal drawers Authorized reagents Reagents authorized by Grifols Reagent vials 17 ≤ Ø ≤ 21.3 mm diameter Positive automatic reagent identificiation Yes, by barcode reading System solutions Grifols DG Fluid A diluted for the fluidic system Grifols DG Fluid B diluted for external washing and final washing of the fluidic system Containers and capacity 1 container for Grifols DG Fluid A (6 L) (extendable to 12 L*) 1 container for Grifols DG Fluid B (6 L) (extendable to 12 L*) 2 containers for waste solutions (6 L/each container) 1 container for processed card disposal (up to 100 fully used cards) *With optional waste liquid drainage CARD STATION Loading capacity A maximum of 200 cards (1600 tests) Loading system DG Gel® card racks, directly in the 2 independently opening drawers Service rack 12 positions Continuous loading and unloading Yes Number of different DG Gel® card types on board Up to 8 different DG Gel® card types Waste liquid drainage Option to drain waste liquid directly to the laboratory drainage system Container weight (when full) ≥ 6 kg Container monitoring Yes, by monitoring the volume by weight OTHERS Total speed • Maximum throughput: 50 cards/ hour (400 results/hour)1 • Full ABO/Rh blood group typing: 35 samples/h2 • Antibody screening (I, II, III): 72 samples/h • Type & Screen: 23 samples/h3 CENTRIFUGES AND INCUBATORS Number of centrifuges 2 independent centrifuges Useful life 7 years Centrifugal capacity 12 cards per centrifuge (total 24 cards) Outputs to peripherals Centrifugation time 9 minutes Standard interfaces: • 3 RS232 connections • 8 USB ports (4 front, 4 rear) • 2 LAN connections Incubation time 15 minutes (as needed) Remote connection Incubation temperatures 24ºC and 37ºC (depending on the requested tests) Number of incubators 3 independent incubators Incubator capacity 12 cards/incubator Yes, the web application provides access for authorized OPERATORS to: • Worksheet • Results • Database • Quality Control • User management Remote diagnostics: technical/ specialist support can remotely connect to the system READING STATION Reading system High-resolution color reading using a CCD camera Throughput depends on the profiles being processed: 1 Results obtained with DG Gel® Rh Pheno + Kell 2 Results obtained with DG Gel®ABO/Rh (2D)(profile: A, B, AB, D1, D2, Ctl., N/A1, N/B) 3 Results obtained with DG Gel® ABO/Rh (2D) and antibody screening (I, II, III) REGULATIONS The Erytra Eflexis® analyzer is CE marked in accordance with the Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices SOFTWARE SPECIFICATIONS Operative system W7 Software installed Erytra Eflexis® software Antivirus McAfee Embedded Control program LIS connection protocol ASTM protocol Grifols International, S.A. Parc Empreserial Can Sant Joan Av. de la Generalitat, 152-158 08174 Sant Cugat del Vallès Barcelona - SPAIN Tel. (+34) 935 710 500 Fax. (+34) 935 710 267 Diagnostic Grifols S.A. Pg. Fluvial, 24 08150 Parets del Vallès, Barcelona - SPAIN Tel. (34) 935 710 400 © 2016 Grifols International, S.A. All rights reserved - Functional specifications