Related Manuals for DIALAB DIAcheck C1
Summary of Contents for DIALAB DIAcheck C1
- Page 1 Operation Manual DIAcheck Series C1 / C2 / C4 For In-Vitro Diagnostic use Instrumentation and reagents for human coagulation and hemostasis Copyright © 2018, Dialab GmbH, Austria OPM Revision 4 Firmware V01.01.44 Issue Jun-2018...
- Page 2 Dialab GmbH. The software for Dialab GmbH products is the intellectual property of Dialab GmbH, which company retains all rights to usage of the software. The purchaser of a DIAcheck series acquires rights of use...
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Page 3: Table Of Contents
Dialab GmbH Introduction ............................7 Symbols ............................7 Views of the device ......................... 8 Consumables / Accessories ....................9 Intended use ........................... 10 1.4.1 Compare of DIAcheck series ...................... 10 1.4.2 Test Methods ............................ 12 1.4.3 Specimen Collection ........................12 1.4.4... - Page 4 Dialab GmbH Operation of the DIAcheck series ....................26 Homescreen..........................26 Input patient identification ....................27 Test selection ......................... 28 Measurement ......................... 29 System settings ........................30 Test Settings ........................... 34 Review results ........................36 Basis coagulation tests ........................37 Quickguide of PT Determination ..................
- Page 5 Dialab GmbH Cleaning ........................... 53 Decontamination ........................53 Regular mainentance ......................53 10. Appendix ............................. 54 10.1 Barcode Guideline ........................ 54 10.2 Technical data ........................55 11. Index ..............................56 Operator's Manual DIAcheck series Rev-4 Page 5...
- Page 6 Figure 13: Quickmenu DIAcheck series C2/C4 ................30 Figure 14: System settngs DIAcheck series C2/C4 ................. 32 Figure 15: Menu / System settings DIAcheck C1 ................33 Figure 16: Test setting 1 ........................34 Figure 17: Test Setting 2 ........................35 Figure 18: Review results DIAcheck series C2/C4 ................
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Page 7: Introduction
Dialab GmbH 1. INTRODUCTION This device left the factory in fault-free condition regarding its safety and engineering functionality. To maintain this condition and ensure risk-free operation, the operator must comply with the safety warnings and information in this Operator's Manual. -
Page 8: Views Of The Device
Dialab GmbH VIEWS OF THE DEVICE Home Screen Coloured Touch Display Complete area is prewarmed to 37°C 1 x Reagent position Ø24mm 1 x Reagent position Ø22mm 1 x Reagent position Ø22mm, stirred 2 x Reagent positions Ø13mm 20 x Cuvette incubation positions... -
Page 9: Consumables / Accessories
Dialab GmbH CONSUMABLES / ACCESSORIES Single cuvettes Reagent adapter ∅ 24,5 22,5 mm Stirring magnets, P=4 External CCD-Barcode Reader only connectable, if no internal Barcode-Reader is built-in Thermal printer 60mm TECAM Smart Software Patient management, Monitoring, Research, Statistics, Mirror print... -
Page 10: Intended Use
Dialab GmbH INTENDED USE The DIAcheck series is designed to carry out coagulometric tests such as PT, PTT, TT, fibrinogen, single factor tests, chromogenic and immunoturbidimetric tests (for instance Antithrombin, D-dimer etc.) on human citrated plasma. The instrument has to be used for the expected purposes and in perfect technical condition, by qualified personnel, in working conditions and maintenance operations as described in this document. - Page 11 Dialab GmbH Special Clotting Assays All factors All factors Chromogenic Assays AT, PC AT, PC Latex enhanced Assays D-Dimer D-Dimer D-Dimer Whole Blood Testing Yes (PT INR+%) DOAC monitoring HEP,LMW,APIX, HEP,LMW,APIX, (based on anti IIa and anti Xa) RIVX,EDOX,DABI RIVX,EDOX,DABI...
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Page 12: Test Methods
Dialab GmbH 1.4.2 TEST METHODS Following test are provided to detect of the human coagulation system, which can be bleeding or thrombosis and the monitoring of anti-coagulation drugs like Heparin or Marcumar. DIAcheck series Test Name Specimen Method Prothrombin Time... -
Page 13: Principle Of Measurment
Dialab GmbH 1.4.4 PRINCIPLE OF MEASURMENT The detection of plasma clotting is based on a photometric principle. No mechanical aids like mixing bars are required. Blood plasma is filled into a cuvette. Special reagents are added, which initiate the blood coagulation. The cuvette is transmitted by ultra violet light during the coagulation process. -
Page 14: Clotting Method (Pt, Aptt
Dialab GmbH 1.4.5 CLOTTING METHOD (PT, APTT,..) FIGURE 4: DETERMINATION OF TURNING POINT IN CLOTTING METHOD The final reaction in the coagulation cascade is the transformation of fibrinogen into fibrin catalyzed by thrombin. Fibrin formation results in clouding (higher turbidimetric level) in the sample, which is measured by the photometer and stored as the extinction. -
Page 15: Safety Information
1.5.2 SAFETY INFORMATION FOR MATERIALS Use only Dialab approved and labeled material like cuvettes, spare parts or reagents for which the instrument is intended and validated for. Consumables like cuvettes or yellow tips are intended as single-use items. -
Page 16: Safety Information Regarding Risk Of Health
Dialab GmbH 1.5.3 SAFETY INFORMATION REGARDING RISK OF HEALTH Bleeding or Thrombosis Diagnosis and medication of human coagulation system based on false results may lead to critical bleeding or thrombosis. For risk reduction it is essential to follow the hints below. -
Page 17: Safety Information For Cleaning, Maintenance And Servicing
Dialab GmbH 1.5.4 SAFETY INFORMATION FOR CLEANING, MAINTENANCE AND SERVICING Authorized service only! Carry out only the measures listed in this operator’s manual for maintenance, repair and replacement. Improper manipulation of the device will void the manufacturer's liability obligations and may make service calls necessary, including payments which are not covered by warranty. -
Page 18: Electrical Safety
Dialab GmbH 1.5.5 ELECTRICAL SAFETY Precautions: Avoid spilling liquids into system. In case of spilled liquids disconnect the system from power, then clean and dry all contaminated parts. Remove the power cord before opening the instrument. Do not touch any electronic parts during operation. -
Page 19: Installation Of The Diacheck Series
Dialab GmbH INSTALLATION OF THE DIACHECK SERIES SCOPE OF DELIVERY Contents of standard delivery package: • 1 Pc DIAcheck instrument 1 Pc Power Supply • 2x100 Pcs Single cuvettes • • 5 Pcs Reagent container, Ø22,5mm • 5 Pcs Reagent tubes, Ø11mm •... -
Page 20: Conditions Of Operation
Dialab GmbH CONDITIONS OF OPERATION Ambient conditions: Operating Temperature 15°C to 30 °C Humidity < 70% rel. humidity Elevation above NN sea level < 3,000m Free of dust Grade 2 Impact resistance According to IEC/EN 61010-1, 8.2.2 Not allowed Vibrations, direct sun light and direct exposure to air condition. -
Page 21: First Installation
Dialab GmbH FIRST INSTALLATION Inspect the packaging of the DIAcheck series and accessories for any visible external damage. If the packaging is damaged, contact the transport company so that any damage to the device or accessories can be assessed. The instrument is ready to use and don’t need a specific procedure. -
Page 22: Switching On And Off
Dialab GmbH SWITCHING ON AND OFF Switching on Connect with power supply Important Information: The instrument requires about 15 minutes to heat up the optic block to 37°C. Afterwards it is ready for measurement, indicated by a green dot in the top right corner of the display. -
Page 23: Display Protection Foil
Dialab GmbH DISPLAY PROTECTION FOIL Requirements: Type: Touchseinsitive Protection foil, clean tissue wet and dry, Peel-off- plate Size: same as Display (4,3”) Installation: Ready to fix on display, as described in the Inlay (clean display with clean tissues wet and dry and fix protection foil carefully) -
Page 24: Tecam Smart
Dialab GmbH TECAM SMART Requirements: License: TECAM SMART fingerprint and activation code. Cable: USB, type A to B, max 3m Interface: Setting: no handshake or protocol. Barcode must be finished with carriage return. Installation: a) Disconnect the device from PC. -
Page 25: Registration
Dialab GmbH REGISTRATION The instrument must be registered online for warranty or service issues 1) Open weblink www.dialab-reg.com or scan QR Code on ID-Card 2) Enter SIN + PIN of device Both can be seen on instrument license plate (Type label) or during startup or on info... -
Page 26: Operation Of The Diacheck Series
Dialab GmbH OPERATION OF THE DIACHECK SERIES HOMESCREEN After boot or home button following screen is displayed FIGURE 8: HOMESCREEN DIACHECK SERIES C4 UI Element Element Name Use Function Date & Time Edit date Current test Change test Stopwatch Start/Reset stopwatch or countdown... -
Page 27: Input Patient Identification
Dialab GmbH INPUT PATIENT IDENTIFICATION Call: Homescreen/Optic button FIGURE 9: INPUT PATIENT ID Button UI Element Use Function Numeric keys 0-9, C, X Change or delete PID. Increment PID. Use long touch feature Increment -1 / +1 for easy change. -
Page 28: Test Selection
>> << Change test table Activate two LOTs per test (not available On / Off On / Off for DIAcheck C1). LOT 1/2 LOT 1 / LOT 2 Load calibration of LOT 1 or LOT 2 from memory. < OK Confirm test for current channel. -
Page 29: Measurement
Dialab GmbH MEASUREMENT FIGURE 12: SCREEN DURING MEASUREMENT Button (7) during measurment Patient identification number (max 16 numbers). Result PT = 12.5s, 115% 0,91 INR. +++ = no clot reaction detected within runtime. FlagFehler! Textmarke nicht definiert. f = very low fibrinogen (weak clot). -
Page 30: System Settings
Dialab GmbH SYSTEM SETTINGS Menu and functions depend on instrument version C1 or C2/C4 ! Call: Homescreen/Menu button FIGURE 13: QUICKMENU DIACHECK SERIES C2/C4 Button UI Element Use Function Toggle Auto Auto PID Enable/Disable the Auto PID feature. Double Toggle Double Enable/Disable Double determination. - Page 31 Dialab GmbH Double determination: When using double determination mode, the channels 1 / 2 (DIAcheck C2) respectively channels 1 / 2 and 3 / 4 (DIAcheck C4) are combined to perform a test using the same ID twice. Both results are combined by calculating the mean value.
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Page 32: Figure 14: System Settngs Diacheck Series C2/C4
Dialab GmbH Call: Homescreen / Menu / Setup FIGURE 14: SYSTEM SETTNGS DIACHECK SERIES C2/C4 Setting/Buttons UI Element Use Function Date Date | < | > Set system date, use long touch on “<” “>” to scroll through the values faster. -
Page 33: Figure 15: Menu / System Settings Diacheck C1
Info Open system information. The functionality of the options on the setup screen for the DIAcheck C1 are the same as for the DIAcheck C2 and DIAcheck C4. For detailed information about the available functions see the setup screen for the DIAcheck C2 and DIAcheck C4. -
Page 34: Test Settings
Dialab GmbH TEST SETTINGS Call: Homescreen / Test button / Settings FIGURE 16: TEST SETTING 1FEHLER! TEXTMARKE NICHT DEFINIERT. Setting/Buttons UI Element Use Function LOT Number field Press the LOT text field to enter or change LOT number. Expiry Expiry date field... -
Page 35: Figure 17: Test Setting 2
Dialab GmbH Stop: Some samples do not clot. Afer stop time instrument breask measurement and report “+++” (no clot detect) Call: Homescreen / Test button / Settings / Settings FIGURE 17: TEST SETTING 2 Setting/Buttons UI Element Use Function Calibration curve Value fields Press a calibration value to select the field. -
Page 36: Review Results
Dialab GmbH REVIEW RESULTS Menu not available for version C1 Call: Homescreen / Menu / Results FIGURE 18: REVIEW RESULTS DIACHECK SERIES C2/C4 Setting/Buttons UI Element Use Function Result selection <, > Navigate the results. Print result Print Print the shown result. -
Page 37: Basis Coagulation Tests
10. Wait for result or touch optic button to abort. Multi-Activation (not for DIAcheck C1) 1. Open menu and set Auto PID = On. 2. Place empty cuvettes into each channel and pipet 25µL of sample to each cuvette. -
Page 38: Quickguide Of Pt-B Determination
Dialab GmbH QUICKGUIDE OF PT-B DETERMINATION How to run a PT-B measurement from finger blood: 1. Switch on instrument and wait for green state (~ 15min until 37°C). 2. Change test to “PTB” by pressing on the current test. 3. Reconstitute PT-B with component-1 (Diluent) and wait 30-60 min before next step. -
Page 39: Quickguide Of Fib Determination
Dialab GmbH QUICKGUIDE OF FIB DETERMINATION How to run a FIB measurement: 1. Switch on instrument and wait for green state (~ 15min until 37°C). 2. Change test to “FIB” by pressing on the current test. 3. Reconstitute FIB reagent and wait 30-60 min before next step. -
Page 40: Ticket System
Dialab GmbH TICKET SYSTEM webpage: www.dialab-reg.com 1) Login to ticket system DIAcheck C4 Version: V03.00.45 www.dialab-reg.com SIN: 03040 01234 PIN: 12345 67890 Det=241 Enter SIN and PIN of instrument! This information can be found on instrument license plate (Type label) or on info screen. -
Page 41: Figure 21: Ticket System, Input Code
Dialab GmbH 3) Transfer ticket code to instrument Open info screen (touch blinking RED LED) and then “Remaining tests=0”. The code can be transfered by manual input, barcode scanner or TECAM SMART software. FIGURE 21: TICKET SYSTEM, INPUT CODE 4) Using TECAM SMART software... -
Page 42: Service Functions
Dialab GmbH SERVICE FUNCTIONS Only for authorized and trained persons. Unqualified modifications can cause troubles and misfunction of the system! SYSTEM INFORMATION Call: Homescreen / green or red LED DIAcheck C4 Version: V03.00.45 www.dialab-reg.com SIN: 03040 01234 PIN: 12345 67890... -
Page 43: Optic Check
Dialab GmbH OPTIC CHECK Call: Homescreen / green or red LED / Optic FIGURE 24: OPTIC CHECK Button Caption Use Function (1)-(4) OPTIC xx Reset QC value I=mA Display and change intensity of LED Return to homescreen Set all LED to max. intensity (42mA) -
Page 44: System Report
Dialab GmbH SYSTEM REPORT Call: Homescreen / green or red LED / Print SYSTEM REPORT 22.08.2017 Date of report System: DIAcheck name of system Version: V3.01.45 software version SIN : 03040 01234 system ident number PIN: 12345 67890 product ident number TEMP: 37.0°C... -
Page 45: Adjust Temperature
Dialab GmbH ADJUST TEMPERATURE Call: Homescreen / Menu / Temperature 1. Switch on device and wait approx. 15min until system show 37°C on screen. 2. Fill a reagent tube/vial with 2 ml water and place it in a reagent position. Place a digital thermometer in the reagent tube and let warm-up for approx. -
Page 46: Firmware Update
Dialab GmbH FIRMWARE UPDATE Only for authorized and trained persons. Sudden interruption of power or data communication during update procedure will cause device not to boot anymore. In this case, the instrument can be restored only by JTAG interface. 1. Download flashdisk.exe from manufacturer website. Contact local distributor to receive correct URL address. -
Page 47: Overview Of Mainboard
Dialab GmbH OVERVIEW OF MAINBOARD FIGURE 26: MAINBOARD Testpin Function: TP1 = Systick Interval, must toogle each 1ms TP2 = indicate reading of SD24 TP3 = draw homescreen TP4 = Write to EEprom TP5 = Read from to EEprom Other = not used... -
Page 48: Typical Failures
Dialab GmbH TYPICAL FAILURES Malfunction / Error Possible cause Measures System not ready different Open system info and User check red errors Remaining tests = 0 No cuvette activated Create a ticket User ERR=Comm Mainboard defect replacement Authorized service ERR=SWCORE... -
Page 49: Hidden Functions
Dialab GmbH HIDDEN FUNCTIONS RESET TO FACTORY DEFAULT System factory reset procedure: WELCOME SCREEN + FACTORY DEFAULT How to reset to factory default: Press 3sec to spinner during boot up Select “OK” Switch on device and switch to home screen Confirm the reset ... -
Page 50: Login As Admin
Dialab GmbH LOGIN AS ADMIN FIGURE 27: ADMIN LOGIN 1. Break welcome screen: Long press on spinner icon 2. Touch alternative: zone 1, 2, 1, 2, 1, 2 As admin following functions are enabled: Change test protocol (see next chapter) •... - Page 51 Dialab GmbH Setting Select Function Clot = clotting assay METHOD CLOT/CHROM Chrom = chromogenic or immunturbimetric test Definition of clotting time CLOT method: 30-70% 30% =shorter results, close to start of reaction 70% =longer results, close to end of reaction...
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Page 52: Working With Tecam Smart
Dialab GmbH WORKING WITH TECAM SMART Detailed information about installation and operation be be read in the online manual of TECAM. This is just a quick overview. TECAM software is a small local LIS and combines laboratory data management, quality control and research purpose in one. -
Page 53: Cleaning And Maintenance
Dialab GmbH CLEANING AND MAINTENANCE GENERAL CLEANING INFORMATION • Clean with a lint free cotton cloth or stick • Never pure any liquid into optic, working area or touch display • Keep the device free of dust and moisture. • If the device is soiled with liquids, remove the soiling with an absorbent cloth. -
Page 54: 10. Appendix
Dialab GmbH 10. APPENDIX 10.1 BARCODE GUIDELINE Specification of label: - Label length: 50 – 70 mm - Label height: 20 - 30 mm - Barcode length: 40 – 60 mm - Barcode height: 10 - 20 mm - Quiet zone: >5mm... -
Page 55: Technical Data
Dialab GmbH 10.2 TECHNICAL DATA Analyzer Display capacitive touch sensitive TFT 4.3’’ 480x272 Measurement system 1-4 independent measurement channels wavelength of LED 405 nm Cuvette single channel cuvette for optical detection Positions (prewarmed) 5 reagent positions at 36.5 – 37.5 °C 20 cuvette positions at 36.5 –... -
Page 56: Index
Dialab GmbH INDEX +++ ........35 green ........26 Safety information . 15, 16, 17 admin ......... 34 Hemoglobin ....... 12 Scope of delivery ....19 Admin ........ 50 hidden functions ....49 screensaver ......26 Ambient conditions ... 55 hi-sense ......
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