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13. List of claims and instrument disinfection procedure  

 

Serial number of instrument: __________________ 

 

Detailed description of the defect: ___________________________________________ 

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Means used for disinfection: _________________________ 

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Procedure of instrument disinfection: __________________________________________ 

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Full name: _________________________________________ 

Position: ________________________________________ 

Company: ______________________________________ 

  Signature: _____________________ 

 

Date: ________________________ 

 

 

Summary of Contents for DTprime

Page 1: ...Operation Manual DTprime Real Time PCR instrument PART I Operating Procedure TS 9443 004 96301278 2010 DNA Technology Research Production LLC Protvino...

Page 2: ...2...

Page 3: ...is may result in breakdown 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...

Page 4: ...rect biological hazard Servicing and maintainance of the instrument should be performed by specially trained qualified staff While operation with the instrument wear suitable protective clothing glove...

Page 5: ...tion protected by copyright No part of it may be reproduced without preliminary written consent of DNA Technology Research Production LLC Any software products equipment and designations mentioned in...

Page 6: ...4 2 Preparing the Instrument for PCR 30 4 2 1 Checkup of Geometrical Settings 30 4 2 2 Optical Measurement Exposure Setting 31 4 2 3 Checking the Cleanness of Thermal Plate Wells 32 4 2 4 Tubes Height...

Page 7: ...me PCR The qualitative analysis is based on evaluation of kinetics of PCR visible part carried out using relevant mathematical tool The use of fluorescent detection of PCR products has a list of subst...

Page 8: ...paration and initialization of experiments on the instrument is realized with an IBM compatible personal computer and further implementation of a preset program may be executed autonomously On complet...

Page 9: ...ent RT96 01IN DNA Technology R P 1 2 Instruction for use Part I and Part II RT96 04IFU DNA Technology R P 1 3 Computer communication cable USB 2 0 High Speed China 1 4 Power cable 10 250V 3 0 75mm2 Ta...

Page 10: ...100 modification M Maximum heating ramp rate within temperature range of 0 100 modification M 3 3 C s 3 5 C s Average cooling rate within temperature range of 100 55 modification M Maximum cooling ra...

Page 11: ...an be changed within the specified limits 450 750 nm in accordance to customer request 1 4 Operating Conditions The instrument is intended for the use indoors under the following climatic conditions i...

Page 12: ...ule which consists of sources of excitation based on LEDs and detection based on CCD camera optical path module for transporting light beams slide for the thermal block placement hot lid module which...

Page 13: ...13 Fig 2 Front view of DTprime instrument The instrument rear panel accommodates the following fig 3 power switch two fuses power input USB connection type B Fig 3 Rear view of DTprime instrument...

Page 14: ...0 mm in horizontal and vertical planes correspondently and provides easy access to the tubes The hot lid module provides a reliable heat contact between tubes and the thermal plate and allows maintain...

Page 15: ...the thermal block for placing the tubes into the thermal plate before PCR running precise positioning of the thermal block under optical elements in their operating position When the instrument operat...

Page 16: ...2011 EN 61010 1 2010 EN 61010 2 101 2018 Below provided example of the label on the rear panel of the instrument The following warning signs Fragile Top Keep dry Stacking is forbidden are placed on th...

Page 17: ...17 Symbols used for marking For in vitro diagnosis only Storage requirements temterature Fragile Top Keep dry Stacking is forbidden Date of production Manufacturer details High voltage...

Page 18: ...d condition by two persons or using movable table trolley to other preliminary prepared working place in accordance with corresponding precautions Note In case the instrument is transported over long...

Page 19: ...on PC The software operates in Windows 98 Windows ME Windows 2k XP Windows Vista Windows 7 Windows 8 Windows 10 Software installation is required only if the instrument and PC are purchased separately...

Page 20: ...puter open Device Manager window then right click DT 964 and select Update driver in the list In the next window Driver Updating select Manual driver search and installation click Browse select Driver...

Page 21: ...nstallation Select Install from a list of specific location and click Fig 6 Fig 7 Searching Drivers_DT96x folder on the USB flash drive Select a path to the driver folder by ticking Add this location...

Page 22: ...t Drivers_DT96x folder on the USB flash drive and click Fig 8 Making sure the driver folder path is correct click Fig 9 Fig 9 Selecting inf file on the USB flash drive Select the latest version of the...

Page 23: ...er selection by clicking Fig 10 Select the path to Dt964 sys file on the CD by clicking Fig 11 Fig 11 Selecting the path to Dt964R sys file on the CD In the next window Locate file find this file in t...

Page 24: ...s file selection on the USB flash drive Making sure that the path to the file in the window Fig 11 is correct click After message that the installation of the driver has been completed Fig 13 click Fi...

Page 25: ...privileges Make sure you are logged in with administrative privileges Installation of RealTime_PCR software should be performed as follows Launch Setup manager from the USB flash drive included in the...

Page 26: ...g 16 RealTime_PCR software can be installed into a default folder or any folder on the hard disk by clicking installation into a default folder is preferable Fig 16 Folder selection to install softwar...

Page 27: ...Time_PCR shortcuts will be created and click Fig 17 Fig 17 Selecting of folder to create shortcuts Confirmation window will appear informing that software is ready for setup Fig 18 Check the chosen op...

Page 28: ...the corresponding Server_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 displayed in the tray and stays acti...

Page 29: ...ect another operator by using drop down menu or add a new one drop down menu last line Please type in the name of Operator and select the Directory where run protocol files and assay results be stored...

Page 30: ...icking and in the List of devices window which is displayed automatically at the launch of RealTime_PCR and while operating this window can be opened by clicking Preferences List of devices at the men...

Page 31: ...r 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 sig...

Page 32: ...ity of the wells before placing tubes strips or plates with PCR mixes if there was a risk of contamination before Note Routine check of well cleanness must be carried out by the operator in compliance...

Page 33: ...saved standard assay parameters recommended for standard assays in clinical laboratories by using plate protocol templates saved before Note Do not fill in the plate protocol without using Test proce...

Page 34: ...ill be displayed as the default If the plate protocol was filled in without using the Test procedure the amplification program of the last run will be displayed If required the following steps may be...

Page 35: ...n of amplification program using template Fig 26 Edit of existing amplification program Creating and editing the amplification program are described in details in the second part of operation manual S...

Page 36: ...ck manual control and wait until the thermal block is opened Fig 27 2 If it is the first start of the instrument rub the wells of the thermal block with a cloth moistened in alcohol 96 ethanol or 100...

Page 37: ...panel of it is made flexible Caution hot surface During the instrument operation the matrix of thermal block and hot lid may get hot up to 100 and 105 C respectively When execution of the PCR RUN ope...

Page 38: ...ing diode on the front panel of the instrument Note The instrument will proceed to the sleep mode only if Turn off device after the run option is activated and the executed amplification program finis...

Page 39: ...this case a blinking message Holding and a information about storage temperature will appear on the chart Fig 29 Message about the RUN completion The same message will appear on the instrument displa...

Page 40: ...s The maintenance of the instrument is necessary to keep it at optimum working condition which minimises the risk of having unscheduled downtime and providing for its maximum operational life The inst...

Page 41: ...periodicity treated with disinfectant solutions to eliminate possible contamination of it by amplification products of nucleic acids in accordance to local regulations and rules Cleaning of thermal b...

Page 42: ...lfunctioned Please contact local service office or service department of the manufacturer During the amplification pro gram execution the following error message is displayed Error Program is running...

Page 43: ...ccordance with the requirements stipulated by existing Federal laws and in compliance with the mandatory requirements for environmental protection in accordance with the local regulations 8 EMS declar...

Page 44: ...y of the provided software with any hardware or software supplied by other manufacturers unless otherwise stipulated In no event shall the manufacturer and seller be liable for any losses including lo...

Page 45: ...he packed product is accepted by ____________________ signature L S Note The form is to be filled in at the factory that packed the product 11 Acceptance certificate DTprime Real Time PCR instrument S...

Page 46: ...46...

Page 47: ..._____ manufacturer s name 201 manufacturer s stamp date personal signature Owner and his address personal signature CARD No 2 to be filled in by the manufacturer For warranty repair maintenance of DTp...

Page 48: ...ct 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 Repair content Date of...

Page 49: ...___________________ Means used for disinfection _________________________ ___________________________________________________________________________ __________________________________________________...

Page 50: ...l info dna technology com Customer support Tel 8 800 200 75 15 free for Russia E mail hotline dna technology ru Feedback form see on DNA Technology s website http www dna technology ru customer_suppor...

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