HumaCLIA 150

SPECIFICATIONS

> System Specifications

> Scope of Supply
> Obligatory items
> Optional items

System Overview REF 15910

Analyzer type Random-access chemiluminescence immunoassay system (CLIA)
Class Benchtop
Reagents System reagents
Throughput range Up to 150 tests/hour
Routine approx. 80 tests/h
Time to first result 12 - 56 min depending on assay
Time to start emergency sample 120 sec (routine Mode)
Reaction / reading system Single use reaction vessels/cuvettes (bulk format)
Operation modes Random access
Batch
STAT (immediate access and execution)
Software languages available English, Spanish*, Chinese*, French*
*will follow after launch
Operating software External control unit with Windows 10 (64 bit), English
HumaCLIA 150
Random access chemiluminescence immunoassay system (CLIA)

Analytical Module Measuring mode Direct chemiluminescence

Detection principle Acridinium ester + H2O2 + NaOH (flash light)
Calculation modes Qualitative & quantitative calculation algorithms
Calculation algorithms Single and multi-mathematic algorithms
# of programmable tests Unlimited (test buttons 9 x 4 x 3)
# of programmable profils Unlimited (test buttons 9 x 2 x 3)
# of standards per test 2-4
Calibration mode 2D Barcode master curve
Multiple point master curve re-calibration
Methodologies One- Step 1, One-Step 2, One-Step 3, Two-Step 1 and Two-Step 2

Sample / Control / Sample type Serum, plasma, urine, CSF (cerebrospinal fluid),
Calibrator Handling PPF (plasma protein fraction), saliva
Supported sample vessels Primary/secondary tubes length 72 - 100 mm, Ø 13-16 mm;
11 mm plasma tubes by adapter;
Sample cups length < 100 mm, Ø: 14 mm
e.g. Hitachi/Eppendorf cups (50 µl dead volume);
Calibration Tubes
Sample positions 50 Positions (10 Racks with 5 sample tubes) / STAT
Sampling volume 5 to 150 µl / test
Loading Continuous (samples and consumables)
Reagent loading (reagents w/o interruption of analysis)
Pre-dilution Automatic predilution of samples
Auto-reflex testing Customizable assay profile definitions
Auto-dilution Auto-dilute high titer sample (retest with dilution if sample got high titer)
Predilution Automatic predilution of samples
Auto-rerun Customizable, according to reference and/or measurement range
Sample barcode identification 1D barcode
Supported sample barcode types Coda bar, Code 39, Code 128, ITF (interleaved 2 of 5 Barcode)

Reagent Module Reagent positions 20 (cooled at 2...8°C)

Trigger/ Pre-Trigger 30 - 37°C
Loading Continuous
Trigger volume 220 ml
Inventory management Assay kit type (name, lot, calibration status, calibration vadility)
Remeaning tests , Trigger / Pre-Trigger (lot)
Reagent barcode scanner Internal 1D Barcode for reagent cardridge
External barcode scanner (Trigger / Pre-Trigger)

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Reaction Unit / Incubation Reaction vessels/cuvettes Single cuvettes/vessels
Onboard capacity of vessels/cuvettes 1000
Waste capacity of vessels/cuvettes 300
Reaction volume (minimum) 50 µl
Reaction volume (maximum) 250 µl
Incubation capacity 75 vessels/cuvettes
Incubation temperature 37°C inside vessel
Temperature accuracy ± 0.3°C
Temperature uniformity/fluctuation ± 0.1°C
Incubation time Depending on assay

Liquid Pipetting Module Liquid transportation Sample X-Z arm

Reagent pipetting arm
Disposable tips Not necessary
Liquid level detection / level sense Sample by capacity
Reagent by tracking with volume and capacity
Probe crash detection Vertical, horizontal
Liquid handling Piston (pipetting)
Injection pump (reagent)
Peristaltic pumps (waste, wash)
Clot detection Sample yes (pressure)
Reagent no
Bubble detection Sampling according to capacity
Reagent by capacity
Precision Sample 2% CV ≥ 5 µl
Reagent 1.5% CV ≥ 20 µl
Trigger / Pre-Trigger 2% CV 200ul/100µl
Accuracy Sample 5 µl ± 5%
Reagent 20 µl ±5%
Trigger / Pre-Trigger 200ul/100µl ± 5%

Washing Capacity wash solution 10 L

Capacity waste container 10 L
Precision Wash 1% CV > 150 µl
Accuracy Wash ±5% @150~710 µl
Fluid alarms Low wash solution,
Waste full

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HumaCLIA 150
Random access chemiluminescence immunoassay system (CLIA)

Reading Module Optical system Photomultiplier

Reading time 4 sec
Light source Chemiluminescence reaction
Accuracy Repeatability of reading CV < 3%
Linearity Linear correlation coefficient r > 0.99

Data Processing User levels 3 (service / administrator / operator)

Interfaces Ethernet / RS232
External barcode reader Scanner hand gun 2D USB
LIS/LIMS Bidirectional, auto-request, auto-send
LIS protocol Yes, HL7/ ASTM E 1394 / ASTM E 1381 protocol
Features Import new methods by 2D barcode,
Full tracability:
Sample = ID / lot / vial no. of reagents
Controls = calibrator lot and time
Consumables (WB, Trigger, Pre-Trigger, Diluent, Reaction cuvettes) = lot
Automatic Maintenance Schedule & recording
Quality control module Mean, SD, CV, standard error and Levey-Jennings in report generation module
Result memory capacity up to 1.000.000 assays records
(including routine samples, emergency samples and quality controls)
# of installable tests Unlimited

Maintenance Daily User < 5 min
Weekly User > 10min
Monthly User < 10 min

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General External PC min. requirements CPU: 3.6 GHz / dual-core /
4 GB RAM / 500 GB HDD / 2 network ports
External screen min. requirements VGA 1440*900 - coloured
User interface Keyboard, mouse, touchscreen
Supported printers All windows compatible printers
Physical dimensions (WxDxH) Instrument w/o any components: 103 x 75 x 71 cm
Space requirements for unpacking: 150 x 200 x 200 cm
Space required for routine use: 230 x 140 x 200 cm
Packaging: Wood Box: 120 x 95 x 90 cm
Accessory Box 1: 60 x 42 x 27 cm
Accessory Box 2: 30.5 x 24.5 x 24.5 cm
Accessory Box 3: 30.5 x 24.5 x 24.5 cm
Weight Gross including packaging: Instrument: 200 kg
Accessory box 1: 11 kg
Accessory box 2: 2 kg
Accessory box 3: 2 kg
Net weight instrument: 160 kg
Electrical requirements 100-240V AC，50/60HZ
Fluctuation ±10% (100VAC -240 VAC) Line frequency ±1Hz
Power consumption: 1000 VA
Online UPS recommended minimum 2000 VA
Environmental Operating temperature: 10… 30° C, Fluctuation ≤ ± 2ºC/h,
Air condition recommended
Transport temperature: 5...55°C ≤93% (without condensation)
Operation humidity: ≤70%RH (without condensation)
Maximum altitude: 2000 m
Noise level Operating mode: ≤ 60 db running
Standby mode: ≤55 db stand by

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HumaCLIA 150
Random access chemiluminescence immunoassay system (CLIA)

Scope of Supply Unit/Size REF

Packlist
HumaCLIA 150 Boxed 1 15910I
HumaCLIA 150 Accessory Box 1 15910AI
HumaCLIA 150 Accessory Box 2 1 15910AI2
HumaCLIA 150 Accessory Box 3 1 15910AI3

Packlist HumaCLIA 150 Accessory Box
User Manual HumaCLIA 150 1 15910/1
Quick Guide HumaCLIA 150 1 15910/5
Software USB Card 1 15910/51
Barcode Reader 1 .........
Sample Rack 19 15910/50
Sample Racks Label - Routine 90 .........
Sample Racks Label - STAT 8 .........
Sample Racks Label - Calibration 5 .........
Sample Racks Label - QC 8 .........
Sample Racks Label - Rerun 8 .........
Ethernet Cable 2 .........
Power Cord - European Standard 1 .........
Waste Box 4 Part of 15910/15
Reaction Vessels 1000 pcs 1 15910/10
Carry Handles 4 .........
Soft Tubing (ABH02017, 1/4*3/8) 10m 1 .........
Soft Tube (ADF49007, 1/8*1/4, ND-100-65) 0.1m 1 .........
Variable Diameter Joint 1 .........
Wash Buffer Tank Sensor 1 .........
Waste Tank Cap (Connectable) 1 .........
Waste Tank Sensor 1 .........
SysCooling Coolant 2 x 500 ml 1 .........
Waste Tank Cap 1 .........
Wash Buffer Tank Cap (Connectable) 1 .........
Centrifugation Tubes 5ml 50 .........
Coolant Injector 150ml 1 .........
Soft Covers - white 28 .........
Empty bottle of reagent 1 .........
Magnetic beads cavity .........
Probe Brush 1 .........
Screwdriver 1 .........
Dust Cover 1 15910/1

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Scope of Supply Unit/Size REF
Packlist HumaCLIA 150 Accessory Box 2
Waste Tank 10 l 1 15910/804

Packlist HumaCLIA 150 Accessory Box 3

Wash Tank 10 l 1 15910/809

Packlist HumaCLIA 150 Additional Accessories

Adapter EU US 1 18967
Adapter EU UK 1 18968
Power safety socket EU 1 18969

Obligatory Items Service Kits Unit/Size REF

Need to be ordered with the first instrument:
Tool Set A 1 15910/505
Tool Set B 1 15910/506
Tool Set C 1 15910/507
Tool Bundle (A+B+C) 1 15910/508

Need to be ordered with each instrument:

Maintenance Kit (Sufficient for 6 months) 1 15910/501
Maintenance Kit (Sufficient for 12 months) 1 15910/500
Maintenance Kit Bundle (Sufficient for 6 and 12 months) 1 15910/502

Consumables
Reaction Vessels HumaCLIA SR 2 x 1.000 pcs 15910/11
Pre-Trigger Solution HumaCLIA SR 4 x 220 ml 80050
Trigger Solution HumaCLIA SR 4 x 220 ml 80055
Wash Buffer 4 x 1 l 80060

Trigger Solution Pre-Trigger Solution Reaction Vessels

REF 80050 REF 80055 REF 15910/11

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 HumaCLIA 150
Random access chemiluminescence immunoassay system (CLIA)

Optional Items Accessories

Windows 10 PC incl. Mouse + Keyboard 18992P
Touch screen Monitor Touchscreen 22 inch 16:9 18995MT
Wash Tank 10 l 1pc. 15910/809
Waste Box 10 pcs. 15910/15

System Reagents

Assay Specifications Assay kit size 2 x 50 tests, including calibrator

Reagent type Liquid, ready-to-use
Reagent onboard stability 28 days
Sample volume (assay depending) 5 - 105 µl average 33 µl
Calibration frequency Calibrate with new lot number, if controls are out of range or
if specified otherwise within package insert

TSH Kit fT3 Kit Immunoassay Multi Control

REF 84600 REF 84620 REF 84850

For more information about available assay please visit: www.human.de/CLIA-reagents

15910 / 2021-05 © 2021 HUMAN

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While Human is making every effort to include accurate and up-to-date information,

we make no representations or warranties, express or implied, as to the accuracy or

completeness of the information provided in this document and disclaim any liability

for the use of it.

HUMAN Gesellschaft für Biochemica und Diagnostica mbH

Max-Planck-Ring 21 · 65205 Wiesbaden · Germany
Tel. +49 6122-9988-0 · Fax +49 6122-9988-100 · e-mail: [email protected] · www.human.de