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16-0042 Erytra Eflexis GLOBAL lr

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