DNA DTlite Operation Manual

DNA DTlite Operation Manual

Real-time pcr instrument

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Operation Manual
DTlite
Real-Time PCR instrument
PART I
Operating Procedure
TS 9443-003-96301278-2010
"DNA-Technology, Research & Production" LLC
Protvino

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Summary of Contents for DNA DTlite

  • Page 1 Operation Manual DTlite Real-Time PCR instrument PART I Operating Procedure TS 9443-003-96301278-2010 “DNA-Technology, Research & Production” LLC Protvino...
  • Page 3 Avoid any liquids or objects getting inside the instrument's cabinet. This may result in break- down of the instrument. “DNA-Technology, Research & Production”, LLC bears no responsibility for any injuries or damage to health caused by unintended use or unauthorized modifications of the instrument.
  • Page 4  the instrument is protected in accordance with IP20 degree. The istrument is IVD medical equipment and it is intended for studing of DNA samples using the polymerase chain reaction (PCR) method and the detection of the accumulated product in real time (real-time PCR).
  • Page 5: Table Of Contents

    Table of Contents Introduction ..........................6 1. General Information ....................... 7 1.1 Intended Use and modifications of the instrument ............... 7 1.2 Delivery Set .......................... 8 1.3 Technical specification ......................8 1.4 Operating Conditions ......................10 1.5. PC Requirements ....................... 10 2.
  • Page 6: Introduction

    Introduction The “DTlite” Detecting Thermocycler (hereafter – the “instrument” or “device”) is intended to conduct qualitative and quantitative PCR analysis dropping out electrophoresis stage of PCR products in agarose gel when using PCR kits based on the fluorescent detection princi- ple.
  • Page 7: General Information

    General Information 1.1 Intended Use and modifications of the instrument The “DTlite” real time PCR instrument is intended for carrying out an assay using polymerase chain reaction (PCR) method and accumulated product detection in a real time (real-time PCR). Detection of the accumulated PCR amplification product occurs directly during the ex- ecution of the amplification program, which increases the informative value of the study.
  • Page 8: Delivery Set

    Instrument is open system and it is not depended of concrete PCR kits. 1.2 Delivery Set Producer Quantity No. Description Reference pcs. DNA- DTlite real time PCR instrument RT48-01SP Technology R&P DNA- Instruction for use (Part I and RT48-04IFU Technology Part II) R&P...
  • Page 9 ±0.2°С Temperature accuracy ±0.3°С Temperature uniformity 3.3°C/s Average heating ramp rate within temperature range of 0…100°С (modification S) Maximum heating ramp rate within tempera- 3.5°C/s ture range of 0…100°С (modification S) Average cooling rate within temperature 2.1°C/s range of 100...55°С (modification S) Maximum cooling rate within temperature 2.5°C/s range of 100...55°С...
  • Page 10: Operating Conditions

    ME, Windows 2k/XP, Windows Vista, Windows 7, Windows 8, Windows 10. 2. Instrument description and principle of operation DTlite is a specialized instrument combining a precise programmable thermal cycler and an optical system to collect fluorescent data at each stage of polymerase chain reaction.
  • Page 11: Fast Thermal Control System

     two fuses;  power input;  USB connection (type B). Fig.2 Rear view of DTlite instrument Caution! The instrument has precision mechanical elements. To avoid displacement of them any shocks during operation and movement of the instrument should be eliminated. When in- strument is moved the thermal block has to be in closed position.
  • Page 12: Optical System

    Movement and positioning module is intended for precise positioning of the thermal unit within 140 mm in horizontal plane, which provides easy access to the tubes. The hot lid module provides a reliable heat contact between tubes and the thermal plate and allows maintaining temperature of the tube caps at the level of 105±1°С...
  • Page 13: Marking. Symbols Used For Marking

    Fig.3 LCD screen and control buttons. Push-button of on-screen menu (left) displays the information on the functions of other panel push-buttons within the given mode of operation. The push-button of thermal block control (in the centre) is intended for launching the fol- lowing operations: ...
  • Page 14 Real-time PCR Detecting termocycler DTlite 4S1 IVD Medical Equipment TS9443-003-96301278-2010 2020 A5I357 The following warning signs “Fragile”, “Top”, “Keep dry”, “Stacking is forbidden” are placed on the shipping box as well as:  trade mark or information about manufacturer;  brand name;...
  • Page 15: Setting Up The Instrument

    Setting up the instrument 3.1 Instrument unpack DTlite real time PCR instrument is delivered packaged in a cardboard or wooden box with inserts of polyethylene foam; the package is intended to protect the instrument from mechani- cal damage when shipped or stored.
  • Page 16: Software Installation

    Switch on PC and wait until the operating system is launched.  Insert the USB flash drive with the drivers into the USB port of PC or download drivers from DNA-technology official website at http://www.dna-technology.ru/eng/support/  Turn on the instrument using the power switch on the back panel.
  • Page 17 Caution! When installing the driver on the PC with Windows 7, Windows 8 or Win- dows 10 operating system, the Found New Hardware Wizard window does not appear automatically. Do the following to install the driver:  After connecting the instrument to the computer, open Device Manager window, then right-click DT-964 and select Update driver in the list ...
  • Page 18 Fig.5 Selecting a type of installation  Select Install from a list of specific location and click (Fig.5) Fig.6 Searching Drivers_DT96x folder on the USB flash drive  Select a path to the driver folder by ticking Add this location to the search and click (Fig.6).
  • Page 19 Fig.7 Selecting the Drivers_DT96x folder on the USB flash drive  In the pop-up window Browse For Folder select Drivers_DT96x folder on the USB flash drive and click (Fig.7).  Making sure the driver folder path is correct (Fig.6), click Fig.8 Selecting inf-file on the USB flash drive Select the latest version of the driver and ignoring message The driver has no digital signa- ture confirm the driver selection by clicking...
  • Page 20 Fig.9 Further Driver_DT96x installation  confirm the driver selection by clicking (Fig.9).  Select the path to Dt964.sys file on the USB flash drive by clicking (Fig.10). Fig.10 Selecting the path to Dt964R.sys file on the USB flash drive  In the next window Locate file find this file in the Drivers DT96x folder on the USB flash drive, select it and click (Fig.11)
  • Page 21 Fig.11 Confirmation of Dt964R.sys file selection on the USB flash drive  Making sure that the path to the file in the window (Fig.10) is correct, click  After message that the installation of the driver has been completed (Fig.12), click Fig.12 Driver installation completion If driver installation is successfully completed, the system will display a message...
  • Page 22: Installation Of Realtime_Pcr Software

    Installation of RealTime_PCR software should be performed as follows:  Launch Setup manager from the USB flash drive included in the delivery set (it can be also downloaded official website http://www.dna-technology.ru/eng/support/).  Select Russian/English language to use during the installation (Fig. 13) and click Fig.13 Selecting a language...
  • Page 23 Fig.15 Folder selection to install software  Having selected the installation folder, click - Select the name of the folder, where RealTime_PCR shortcuts will be created, and click (Fig.16). Fig.16 Selecting of folder to create shortcuts  Confirmation window will appear, informing that software is ready for setup (Fig.17). Check the chosen options and click...
  • Page 24 Fig.17 Confirmation window  After the installation is completed you will see following window (Fig.18). Click to quit the Setup Wizard. Fig.18. Completed operation of the RealTime_PCR installation wizard Caution! To ensure multi-instrument operational conditions, the corresponding Serv- er_RTDevice service is included in the RealTime_PCR software. This service is started at the first start of the software in the mode with sign dis-...
  • Page 25: Operating Procedure

    Clicking the Close Server_RT stops this service at the PC. 4. Operating procedure 4.1. Instrument Switching-on and RealTime_PCR Launch Check whether the instrument is connected to the PC via USB cable, and then switch the in- strument and the PC on. Start the RealTime_PCR software using icon on the Desktop or via the Start menu of the Windows.
  • Page 26 Fig.20 Window of the connected devices Select the instrument to start and click The instrument will be connected to the PC and the indication in the status line of the opera- tion procedure window will be changed to After instrument self testing, indication of its status in the status line will be changed and the instrument will be ready for running the amplification program.
  • Page 27: Preparing The Instrument For Pcr

    Preset parameters of optical measurements for each channel are optimal to operate with DNA-Technology PCR kits and could be suitable for the most of third party kits. Exposure change is required only when levels of different channels’ optical signals substan- tially differ, as it may result in incorrect color compensation in the process of analysis of opti- cal measurements.
  • Page 28: Checking The Cleanness Of Thermal Plate Wells

    Fig.22 Exposure setting window A detailed procedure of exposure value selecting is described in the second part of the opera- tion manual named Software guidance. 4.2.3. Checking the Cleanness of Thermal Plate Wells While checking the optical unit geometrical settings, one has to increase the value of expo- sure in 2 times in comparison with the operational values.
  • Page 29: Creation Of Plate Protocol And Amplification Program

    Caution! To measure tubes height, use at least 16 tubes or 2 strips putting them evenly throughout thermal plate. 4.3 Creation of plate protocol and amplification program After switching on the instrument create or edit of a plate protocol and amplification program using RealTime_PCR software.
  • Page 30: Creation/Editing Of Amplification Program

    Fig.23 Window of plate protocol filling-in 4.3.2. Creation/editing of amplification program After filling in the plate protocol proceed to the Start run tab. The amplification program, specified in the Test procedure used for plate protocol filling in, will be displayed as the de- fault.
  • Page 31: Placement Of Tubes With Samples

    Fig.24 Creation of amplification program using template Fig.25 Edit of existing amplification program Creating and editing the amplification program are described in details in the second part of operation manual Software guidance. 4.4. Placement of tubes with samples To place or remove the test tubes with samples, do the following:...
  • Page 32 Fig.26 Exterior appearance of the thermal block in open position (a – S modification, b – L modification) 1. Click in the Start run tab or push the button of thermal block manual control and wait until the thermal block is opened (Fig.26). 2.
  • Page 33: Startup Of The Amplification Program

    Caution, hot surface! During the instrument operation, the matrix of thermal block and hot lid may get hot up to 100 and 105 ºC respectively. When execution of the PCR RUN (operat- ing mode) the thermal block matrix and the hot lid are not available for operator. Upon com- pletion of the PCR RUN operator is not allowed to remove the tubes from the thermo block until the instrument enters in storage mode (low temperature mode) with the following mes- sage:...
  • Page 34: Amplification Program Running

    4.6 Amplification program running Running of the amplification program is controlled via RealTime_PCR software. The following options could be done during its execution:  pause running;  stop running;  add any number of cycles in a current block or skip execution of the remaining cycles and proceed to the execution of the next temperature block;...
  • Page 35: Maintenance

    Fig.29 Storage mode indication By pressing button ОК RealTime_PCR software is switched to Archive viewer mode (Da- ta analysis tab). If option “Turn off device after the run” was activated, then upon completion of the RUN the instrument switched to the sleep mode. To exit this mode, launch RealTime_PCR soft- ware and again connect to the instrument in the appeared window List of devices.
  • Page 36: Maintenance Procedure

    To keep thermal block matrix and elements of the optical system clean, the instrument ther- mal block has to be always closed (except operations for placement / removal of PCR tubes with samples). To avoid failure of the instrument’s optical system it is strictly forbidden to use any Caution! substances (heat-resistant pastes, oils, etc.) to improve contact between PCR tubes and ther- mal block wells.
  • Page 37: Troubleshooting

    5.4 Troubleshooting Trouble description Probable cause Corrective measures No voltage in the Check if voltage available, socket works mains properly Check the contact of power cord. If After instrument switch-on necessary replace the cable with a simi- there is no information Poor contact or lar one (10A, 250V, 3x0.75mm2), shown on the LCD display...
  • Page 38: Storage And Shipment

    6. Storage and shipment Caution! In case of storage in the cold conditions the instrument has be kept indoor at tem- perature +18 +25 °С during at least 4 hours prior to switching it on. The instrument should be stored indoor with natural ventilation at the temperature range from + 5°C to + 40°С...
  • Page 39: Warranties

    - The instrument uses radiofrequency energy exclusively for its internal function. The level of radiofrequency emission is very low and does not lead to disturb- ances in the operation of electronic equipment located close to it. - It is forbidden to use the instrument near sources of strong electromagnetic radi- ation that could interfere its normal functioning.
  • Page 41: Acceptance Certificate

    10. Packing Certificate “DTlite” Real-Time PCR instrument, Serial number _____________________ manufactured by DNA-Technology, Research & Production, LLC has been packed in accordance with the TS 9443-003-96301278-2010 requirements. Packaging date “……….”………………………., 20 …. The packaging is done by ____________________ (signature) The packed product is accepted by ____________________ (signature) L.S.
  • Page 43: Cards Of Warranty Repair

    12. Cards of warranty repair CARD No. 1 to be filled in by the manufacturer For warranty repair (maintenance) of DTlite Real-Time PCR instrument ………………………………. manufactured by ……………………………………… (factory No. of the product) (date) Representative of the manufacturer’s quality control department ……………………….
  • Page 44 Reverse of CARD No. 1 to be filled in by a service center Product factory No. …………………. Repair content ….…………….………………………………………………………………. ………………………………………………………………………………………………… ………………………………………………………………………………………………… ………………………………………………………………………………………………… ………………………………………………………………………………………………… Date of repair…………………………………. (day, month, year) Serviceman…………………….. Owner…………………………. (signature, stamp) (signature) ………………………………………………………………………………………………… Reverse of CARD No. 2 to be filled in by a service center Product factory No.
  • Page 45: List Of Claims And Instrument Disinfection Procedure

    13. List of claims and instrument disinfection procedure Serial number of instrument: __________________ Detailed description of the defect: _______________________________________________ ___________________________________________________________________________ ___________________________________________________________________________ ___________________________________________________________________________ ___________________________________________________________________________ ___________________________________________________________________________ ___________________________________________________________________________ ___________________________________________________________________________ ___________________________________________________________________________ ___________________________________________________________________________ ___________________________________________________________________________ Means used for disinfection: _________________________ ___________________________________________________________________________ ___________________________________________________________________________ ___________________________________________________________________________ Procedure of instrument disinfection: _____________________________________________ ___________________________________________________________________________ ___________________________________________________________________________ ___________________________________________________________________________...
  • Page 46 _______________. We agree that in case if the instrument is damaged during transportation due to poor-quality packaging, DNA-Technology R&P LLC assumes obligations to carry out maintenance / re- pair procedures after written agreement with the Customer only. Customer:...
  • Page 48 Manufacturer: DNA-Technology, Research & Production, LLC 20 Zheleznodorozhnaya Street, Protvino, Moscow Region, Russia, 142281 Phone/fax: +7(4967) 31-06-70 E-mail: protvino@dna-technology.ru http://www.dna-technology.ru Seller: DNA-Technology, LLC 125Zh Varshavskoe highway, bld. 6, Moscow Russia, 117587 Phone/fax: +7(495) 640-17-71 E-mail: info@dna-technology.com Customer support: Tel.: 8 800 200-75-15 (free for Russia) E-mail: hotline@dna-technology.ru...

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Rt48-01sp

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