DRG BioCheck DxDATA User manual

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Version 1.0
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DRG Instruments GmbH
Frauenbergstrasse 18
35039 Marburg
Germany
Technical Support
USA Phone: [phone]
USA Fax: [phone]
Email: [e-mail]
International Phone: [phone]
International Fax: [phone]
Email: [e-mail]

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Table of Contents
Symbols List ........................................................................................... 4
1. About this manual................................................................................. 5
2. About DxDATATM ................................................................................... 5
2.1 Intended Use................................................................................... 5
2.2 Specifications and performance ............................................................ 6
3. Details of DxDATATM............................................................................... 7
3.1 Principle of detection ........................................................................ 8
3.2 DxDATA TM components....................................................................... 7
4. Storage and Operation of the Equipment.....................................................11
4.1 Environmental conditions and placement instructions .................................11
5. Software Description ............................................................................12
5.1 Software Overview...........................................................................12
5.2 System startup .............................................................................12
5.3 Log in........................................................................................13
5.4 Initialization check ........................................................................14
5.5 Main window ...............................................................................15
5.6 Run window ................................................................................15
5.7 Sample window ............................................................................17
5.8 Results window ............................................................................21
5.9 Settings window ...........................................................................24
5.10 Start initialization.......................................................................30
5.11 Shut down ................................................................................31
6. Instrument warnings and precautions .......................................................32
6.1 Precautions.................................................................................32
7. Troubleshooting ................................................................................33
8. Instrument maintenance ......................................................................35
8.1 Weekly maintenance......................................................................35
8.2 Monthly maintenance .....................................................................35
8.3 Recommended regular maintenance ...................................................35
8.4 Replacing the internal printer paper ...................................................35

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Symbols List
Symbol
Description
Symbol
Description
In Vitro
Diagnostic
equipment
Catalog Number
Serial Number
Consult
Instructions for
use
|
Power on
O
Power off
European
Conformity
Caution
Manufacturer
Waste of electrical
and electronic
equipment
High
temperature,
do not touch
these areas
Biological hazard

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1. About this manual
This manual contains the necessary information for safe, proper, and effective operation of the
DxDATA TM Automatic Chemiluminescent Immunoassay Analyzing System (hereinafter referred to
as " DxDATA TM "). Please read this manual carefully before operating the DxDATA TM.
2. About DxDATATM
This section includes the intended use, operating characteristics, and instrument performance
of the DxDATA TM.
2.1 Intended Use
DxDATA TM is an automated discrete loading chemiluminescence enzyme-linked immunosorbent
assay (CLIA) and magnetic particle separation analyzing system that uses indirect
chemiluminescence based on a chemiluminescent substrate (APS-5) and alkaline phosphatase
for qualitative or quantitative testing, including immune function, autoantibodies, tumor-
associated antigens, myocardial diseases, hormones, proteins and peptides, sugars and their
metabolites, liver diseases, coagulation markers and other items in human serum, plasma and
whole blood samples.

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2.2 Specifications and performance
Instrument type
Automated chemiluminescent immunoassay
analyzing system
Model
DxDATATM
Number of Channels
8-channel parallel detection
Sample material
Whole blood, serum, plasma
Sample volume
30-150l
Wavelength
300-650nm
Data storage
Patient data: more than 100,000 samples (tests)
QC data
More than 100,000 results
Size
400（W) * 610（D) * 645（H）mm
Weight
35 kg
Electrical requirements
110/220 VAC
Rated power supply
110/220V 60/50 Hz 300W
Printer
Built in
Computer
Built in
Screen
10 in LCD touch screen (800 x 600) pixels
Operating System
Microsoft Windows 10 Enterprise

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3. Details of DxDATA TM
This section describes the measurement principle, equipment structure, and accessories used
in DxDATA TM.
3.1 Principle of detection
The detection principle used by DxDATA TM is Chemiluminescent Immunoassay (CLIA), and the
reagents used in each test are stored in a special, individually packaged cassette sealed with
aluminum foil.
The DxDATA TM detection principle is described by applying the sandwich immunoassay reaction
mode. The sample is combined with an alkaline phosphatase-labeled antibody and a biotinylated
antibody to form a sandwich structure. The excess streptavidin-coated magnetic particles form
a complex with the biotinylated antibody, and after washing, the luminescent substrate is
catalytically cleaved by an enzyme in the complex to form an unstable excited intermediate.
When the particle returns to the ground state, it emits photons. The light intensity of the
reaction is detected by a photomultiplier tube, and the luminescence intensity of the analyte is
converted into relative light units (RLU) by the instrument operating software.

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3.2 DxDATA TM components
This section describes the components of the DxDATA TM and their functions.
3.2.1 Front of the Device
The necessary components for operating the DxDATA TM are located at the front and side of
the unit; see the figure below. Component names and functions are described as follows:
The necessary components for operating the DxDATA TM are located at the front and side of
the unit; see the figure below. Component names and functions are described as follows:
•Touchscreen computer - Displays various information about the DxDATA TM
analyzer and accepts input from the user operating the device.
•Printer - Prints results and other information.
•Swing-up door - Open upwards to insert the reagent strip. The reagent strip information
could be read and the experiment program could be selected automatically via the QR
code auto scanning function.
•External bar code scanner - It is linked directly to the USB port at the backside of the
instrument to read the information contained in the QR code.
Door
Touchscreen
Incubator
Printer
External bar code
scanner

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3.2.2 Back of the device DxDATA TM
The supply voltage is 110VAC The supply voltage is 220VAC
The input and output ports of the device are located on the back of the device, as shown in the
figure above.
Switch –This is the main power switch of the device. After the instrument is turned on,
the computer powers up in about 1 minute.
USB –Provides connection to the instrument`s internal computer.
110/220 VAC –Provides connection to the power cable.
Fuse: F2AL250V/F3AL250V –Protects the internal circuitry of the instrument.

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3.2.3 Accessories
Information on the main DxDATA TM accessories is shown in the table below.
Main Accessories Description
Quantity
Remarks
Picture
Power cord
1
Standard
Fuse: F2AL250V/F3AL250V
2
Alternate replacement
Cartridge rack
2
Standard